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Minimally Invasive Surgery Plus Rt-PA for ICH Evacuation Phase III (MISTIE-III)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01827046
Recruitment Status : Completed
First Posted : April 9, 2013
Results First Posted : September 27, 2019
Last Update Posted : September 27, 2019
Sponsor:
Collaborators:
National Institute of Neurological Disorders and Stroke (NINDS)
Genentech, Inc.
Emissary International LLC
Information provided by (Responsible Party):
Johns Hopkins University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Treatment
Condition Intracerebral Hemorrhage
Intervention Drug: rt-PA
Enrollment 499
Recruitment Details Recruitment and randomization occurred at 78 hospitals in USA, Canada, Europe, Australia, and Asia
Pre-assignment Details  
Arm/Group Title MIS Plus Rt-PA Management Medical Management
Hide Arm/Group Description

Subjects randomized to the Minimally Invasive Surgery (MIS) plus recombinant tissue plasminogen activator (rt-PA) management arm will undergo minimally invasive surgery followed by up to 9 doses of 1.0 mg of rt-PA (Activase/Alteplase/CathFlo) for intracerebral hemorrhage clot resolution.

rt-PA: Up to 9 doses of 1.0 mg of rt-PA will be administered through the catheter that was placed directly into the intracerebral hemorrhage using minimally invasive surgery.

Subjects randomized to medical management will receive the standard medical therapies for the treatment of intracerebral hemorrhage, which includes ICU care only and no planned surgical intervention.
Period Title: Overall Study
Started 250 249
Completed 249 240
Not Completed 1 9
Reason Not Completed
Lost to Follow-up             1             5
Withdrawal by Subject             0             4
Arm/Group Title MIS Plus Rt-PA Management Medical Management Total
Hide Arm/Group Description

Subjects randomized to the MIS plus rt-PA management arm will undergo minimally invasive surgery followed by up to 9 doses of 1.0 mg of rt-PA (Activase/Alteplase/CathFlo) for intracerebral hemorrhage clot resolution.

rt-PA: Up to 9 doses of 1.0 mg of rt-PA will be administered through the catheter that was placed directly into the intracerebral hemorrhage using minimally invasive surgery.

Subjects randomized to medical management will receive the standard medical therapies for the treatment of intracerebral hemorrhage, which includes ICU care only and no planned surgical intervention. Total of all reporting groups
Overall Number of Baseline Participants 250 249 499
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Inter-Quartile Range)
Unit of measure:  Years
Number Analyzed 250 participants 249 participants 499 participants
62
(52 to 70)
62
(53 to 71)
62
(52 to 71)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 250 participants 249 participants 499 participants
Female
91
  36.4%
103
  41.4%
194
  38.9%
Male
159
  63.6%
146
  58.6%
305
  61.1%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 250 participants 249 participants 499 participants
Hispanic or Latino
34
  13.6%
34
  13.7%
68
  13.6%
Not Hispanic or Latino
216
  86.4%
215
  86.3%
431
  86.4%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 250 participants 249 participants 499 participants
American Indian or Alaska Native
1
   0.4%
1
   0.4%
2
   0.4%
Asian
12
   4.8%
18
   7.2%
30
   6.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
3
   1.2%
3
   0.6%
Black or African American
46
  18.4%
41
  16.5%
87
  17.4%
White
190
  76.0%
184
  73.9%
374
  74.9%
More than one race
0
   0.0%
2
   0.8%
2
   0.4%
Unknown or Not Reported
1
   0.4%
0
   0.0%
1
   0.2%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 250 participants 249 participants 499 participants
Australia 2 2 4
Canada 3 4 7
China 5 5 10
Europe 41 44 85
United States 199 194 393
Tobacco use  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 250 participants 249 participants 499 participants
50
  20.0%
39
  15.7%
89
  17.8%
Cocaine use  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 250 participants 249 participants 499 participants
11
   4.4%
9
   3.6%
20
   4.0%
On anticoagulants  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 250 participants 249 participants 499 participants
24
   9.6%
10
   4.0%
34
   6.8%
Hormone replacement therapy  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 250 participants 249 participants 499 participants
1
   0.4%
3
   1.2%
4
   0.8%
Hyperlipidaemia medication compliant  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 250 participants 249 participants 499 participants
96
  38.4%
93
  37.3%
189
  37.9%
Antiplatelet therapy  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 250 participants 249 participants 499 participants
67
  26.8%
77
  30.9%
144
  28.9%
Diabetes  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 250 participants 249 participants 499 participants
72
  28.8%
67
  26.9%
139
  27.9%
Hypertension  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 250 participants 249 participants 499 participants
241
  96.4%
240
  96.4%
481
  96.4%
Other cardiovascular disease  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 250 participants 249 participants 499 participants
38
  15.2%
34
  13.7%
72
  14.4%
GCS score at randomization   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 250 participants 249 participants 499 participants
3-8
64
  25.6%
63
  25.3%
127
  25.5%
9-12
111
  44.4%
108
  43.4%
219
  43.9%
13-15
75
  30.0%
78
  31.3%
153
  30.7%
[1]
Measure Description: Glasgow Coma Scale (GCS) scores range from 15 (fully conscious) to 3 (Deep coma)
NIHSS score at randomization   [1] 
Median (Inter-Quartile Range)
Unit of measure:  Units on a scale
Number Analyzed 250 participants 249 participants 499 participants
19
(15 to 23)
19
(15 to 23)
19
(15 to 23)
[1]
Measure Description: NIH Stroke Scale (NIHSS) is a tool used by healthcare providers to objectively quantify the impairment caused by a stroke. The NIHSS is composed of 11 items, each of which scores a specific ability between a 0 and 4. For each item, a score of 0 typically indicates normal function in that specific ability, while a higher score is indicative of some level of impairment. The maximum possible score is 42, with the minimum score being a 0. Stroke severity is scored in the following way:0=No stroke symptoms,1-4=Minor stroke, 5-15=Moderate stroke,16-20=Moderate to severe stroke, 21-42=Severe stroke
Diagnostic CT at presentation - IntraCerebral Hemorrhage (ICH) volume (mL)  
Median (Inter-Quartile Range)
Unit of measure:  mL
Number Analyzed 250 participants 249 participants 499 participants
42.7
(30.4 to 54.5)
41.5
(30.9 to 55.3)
41.8
(30.8 to 54.5)
Diagnostic CT at presentation - IntraVentricular Hemorrhage (IVH) volume (mL)  
Median (Inter-Quartile Range)
Unit of measure:  mL
Number Analyzed 250 participants 249 participants 499 participants
0
(0 to 1.7)
0
(0 to 1.9)
0
(0 to 1.9)
Stability CT(last CT before randomization) IntraCerebral Hemorrhage (ICH) volume (mL)  
Median (Inter-Quartile Range)
Unit of measure:  mL
Number Analyzed 250 participants 249 participants 499 participants
45.8
(35.4 to 59.6)
45.3
(35.4 to 57.2)
45.6
(35.6 to 58.7)
Stability CT(last CT before randomization) IntraVentricular Hemorrhage (IVH) volume (mL)  
Median (Inter-Quartile Range)
Unit of measure:  mL
Number Analyzed 250 participants 249 participants 499 participants
0.3
(0 to 3.1)
0.4
(0 to 3.2)
0.4
(0 to 3.2)
Ventilated at randomization  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 250 participants 249 participants 499 participants
107
  42.8%
102
  41.0%
209
  41.9%
Blood pressure at presentation  
Median (Inter-Quartile Range)
Unit of measure:  Mm Hg
Number Analyzed 250 participants 249 participants 499 participants
Systolic BP (mm Hg)
177
(155 to 208)
176
(158 to 200)
177
(156 to 204)
Diastolic BP (mm Hg)
99
(85 to 113)
98
(84 to 114)
98
(84 to 113)
Blood pressure at randomization  
Median (Inter-Quartile Range)
Unit of measure:  Mm Hg
Number Analyzed 250 participants 249 participants 499 participants
Systolic BP (mm Hg)
138
(130 to 148)
138
(131 to 148)
138
(131 to 148)
Diastolic BP (mm Hg)
70
(63 to 78)
69
(60 to 77)
69
(62 to 77)
Time from stroke to diagnostic CT (h)  
Median (Inter-Quartile Range)
Unit of measure:  Hours
Number Analyzed 250 participants 249 participants 499 participants
2.2
(1.1 to 6.0)
1.9
(1.2 to 4.8)
2.0
(1.2 to 5.1)
Time from stroke to stability CT (h)  
Median (Inter-Quartile Range)
Unit of measure:  Hours
Number Analyzed 250 participants 249 participants 499 participants
36.4
(23.4 to 52.6)
36.3
(23.6 to 48.6)
36.3
(23.5 to 50.2)
Clot location  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 250 participants 249 participants 499 participants
Deep
163
  65.2%
144
  57.8%
307
  61.5%
Lobar
87
  34.8%
105
  42.2%
192
  38.5%
mRS score before stroke   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 250 participants 249 participants 499 participants
0
230
  92.0%
233
  93.6%
463
  92.8%
1
20
   8.0%
16
   6.4%
36
   7.2%
[1]
Measure Description: Score 0 = No symptoms. Score 1 = Having symptoms but no significant disability, and is able to carry out all usual activities.
1.Primary Outcome
Title Dichotomized, Adjudicated Modified Rankin Scale Score 0-3 vs. 4-6 at 365 Days Post Ictus (Adjusted)
Hide Description

Dichotomized, adjudicated, cross-sectional modified Rankin Scale (mRS) score 0-3 vs. 4-6 at 365 days post-ictus, adjusting for baseline (pre-randomization) variables used in covariate adaptive randomization as well as the clinically established severity variables IVH size and ICH location (lobar or deep). Ictus refers to symptom onset.

The mRS is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. It is scored from: 0=No symptoms at all, 1=No significant disability, 2=Slight disability, 3=Moderate disability, 4=Moderately severe disability, 5=Severe disability and 6=death. Dichotomized scores are: 0-3=No symptoms to moderate disability requiring some assistance; 4-6=Moderately severe disability requiring complete assistance to death.

Time Frame Day 365
Hide Outcome Measure Data
Hide Analysis Population Description
Includes participants with mRS scores available at day 365. Number and proportions reported refer to number of participants and proportions with Modified Rankin Score 0-3
Arm/Group Title MIS Plus Rt-PA Management Medical Management
Hide Arm/Group Description:

Subjects randomized to the MIS plus rt-PA management arm will undergo minimally invasive surgery followed by up to 9 doses of 1.0 mg of rt-PA (Activase/Alteplase/CathFlo) for intracerebral hemorrhage clot resolution.

rt-PA: Up to 9 doses of 1.0 mg of rt-PA will be administered through the catheter that was placed directly into the intracerebral hemorrhage using minimally invasive surgery.

Subjects randomized to medical management will receive the standard medical therapies for the treatment of intracerebral hemorrhage, which includes ICU care only and no planned surgical intervention.
Overall Number of Participants Analyzed 249 240
Measure Type: Count of Participants
Unit of Measure: Participants
mRS 0-3
110
  44.2%
100
  41.7%
mRS 4-6
139
  55.8%
140
  58.3%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MIS Plus Rt-PA Management, Medical Management
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.73
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 2
Confidence Interval (2-Sided) 95%
-6.8 to 10.7
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection MIS Plus Rt-PA Management, Medical Management
Comments Adjusted for age, GCS, stability ICH volume, stability IVH volume, ICH deep location
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.33
Comments [Not Specified]
Method Multivariate logit model
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 4
Confidence Interval (2-Sided) 95%
-4 to 12
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Dichotomized Extended Glasgow Outcome Scale (eGOS) Score UGR-US vs. LS-Death at 365 Days Post Ictus (Adjusted)
Hide Description

Dichotomized, cross-sectional extended Glasgow Outcome Scale (eGOS) score upper good recovery (UGR) through upper severe disability (US) vs. lower severe disability (LS) through death at 365 days post ictus, adjusting for baseline (pre-randomization) variables used in covariate adaptive randomization as well as the clinically established severity variables IVH size and ICH location (lobar or deep).

The eGOS is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. It is scored as: 1=Death, 2=Vegetative state, 3=Lower severe disability, 4=Upper severe disability, 5=Lower moderate disability, 6=Upper moderate disability, 7=Lower good recovery, 8=Upper good recovery. Dichotomous variable coding is as follows: 1=codes 4-8, 0=codes 1-3.

Time Frame Day 365
Hide Outcome Measure Data
Hide Analysis Population Description
Those with non-missing mRS scores at 365 days post ictus
Arm/Group Title MIS Plus Rt-PA Management Medical Management
Hide Arm/Group Description:

Subjects randomized to the MIS plus rt-PA management arm will undergo minimally invasive surgery followed by up to 9 doses of 1.0 mg of rt-PA (Activase/Alteplase/CathFlo) for intracerebral hemorrhage clot resolution.

rt-PA: Up to 9 doses of 1.0 mg of rt-PA will be administered through the catheter that was placed directly into the intracerebral hemorrhage using minimally invasive surgery.

Subjects randomized to medical management will receive the standard medical therapies for the treatment of intracerebral hemorrhage, which includes ICU care only and no planned surgical intervention.
Overall Number of Participants Analyzed 244 234
Measure Type: Count of Participants
Unit of Measure: Participants
eGOS UGR-US (4-8)
94
  38.5%
84
  35.9%
eGOS LS-Death (1-3)
150
  61.5%
150
  64.1%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MIS Plus Rt-PA Management, Medical Management
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.55
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 0.03
Confidence Interval (2-Sided) 95%
-0.06 to 0.11
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection MIS Plus Rt-PA Management, Medical Management
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.27
Comments [Not Specified]
Method Multivariate logit model
Comments Adjusted for age, GCS, stability ICH volume, stability IVH volume and ICH deep location
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 1.26
Confidence Interval (2-Sided) 95%
0.82 to 1.97
Estimation Comments [Not Specified]
3.Secondary Outcome
Title All Cause Mortality Longitudinally From Ictus to 365 Days (Adjusted)
Hide Description By group comparison of mortality from ictus to 365 days adjusted for baseline severity.
Time Frame Day 365
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title MIS Plus Rt-PA Management Medical Management
Hide Arm/Group Description:

Subjects randomized to the MIS plus rt-PA management arm will undergo minimally invasive surgery followed by up to 9 doses of 1.0 mg of rt-PA (Activase/Alteplase/CathFlo) for intracerebral hemorrhage clot resolution.

rt-PA: Up to 9 doses of 1.0 mg of rt-PA will be administered through the catheter that was placed directly into the intracerebral hemorrhage using minimally invasive surgery.

Subjects randomized to medical management will receive the standard medical therapies for the treatment of intracerebral hemorrhage, which includes ICU care only and no planned surgical intervention.
Overall Number of Participants Analyzed 250 249
Measure Type: Count of Participants
Unit of Measure: Participants
48
  19.2%
62
  24.9%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MIS Plus Rt-PA Management, Medical Management
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.08
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection MIS Plus Rt-PA Management, Medical Management
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.037
Comments [Not Specified]
Method Adjusted Cox proportional Hazard
Comments Adjusted for age, GCS, Stability ICH volume, Stability IVH volume, ICH deep location, diabetes, cardiovascular disease and race.
Method of Estimation Estimation Parameter Cox Proportional Hazard
Estimated Value 0.67
Confidence Interval (2-Sided) 95%
0.45 to 0.98
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Clot Removal (Amount of Residual Blood)
Hide Description Relationship between clot removal as an Area Under the Curve (AUC) clot-assessment that estimates the time-averaged clot volume from ictus to end of treatment (EOT i.e. 24 hours after last dose) as AUC clot exposure and functional outcome (proportion 0-3 Modified Rankin Scale (mRS)).
Time Frame 24 hours after last dose
Hide Outcome Measure Data
Hide Analysis Population Description
Includes patients who survived through the dosing period
Arm/Group Title MIS Plus Rt-PA Management Medical Management
Hide Arm/Group Description:

Subjects randomized to the MIS plus rt-PA management arm will undergo minimally invasive surgery followed by up to 9 doses of 1.0 mg of rt-PA (Activase/Alteplase/CathFlo) for intracerebral hemorrhage clot resolution.

rt-PA: Up to 9 doses of 1.0 mg of rt-PA will be administered through the catheter that was placed directly into the intracerebral hemorrhage using minimally invasive surgery.

Subjects randomized to medical management will receive the standard medical therapies for the treatment of intracerebral hemorrhage, which includes ICU care only and no planned surgical intervention.
Overall Number of Participants Analyzed 246 239
Mean (Standard Deviation)
Unit of Measure: 10mL x days
mRS 0-3 2.69  (1.11) 4.11  (1.35)
mRS 4-6 3.32  (1.33) 5.26  (1.82)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MIS Plus Rt-PA Management, Medical Management
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Logit model
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.70
Confidence Interval (2-Sided) 95%
0.62 to 0.80
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection MIS Plus Rt-PA Management, Medical Management
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Multivariate logit model
Comments Adjusted for age, GCS, stability IVH volume, and ICH deep location
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.68
Confidence Interval (2-Sided) 95%
0.59 to 0.78
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Patient Disposition: Home Days Over 365 Days Time From Ictus.
Hide Description By group comparison of cumulative days at home during the 365 days post ictus.
Time Frame During 365 days of follow-up
Hide Outcome Measure Data
Hide Analysis Population Description
Includes only patients with cumulative home days at any time during the 365 days of follow-up.
Arm/Group Title MIS Plus Rt-PA Management Medical Management
Hide Arm/Group Description:

Subjects randomized to the MIS plus rt-PA management arm will undergo minimally invasive surgery followed by up to 9 doses of 1.0 mg of rt-PA (Activase/Alteplase/CathFlo) for intracerebral hemorrhage clot resolution.

rt-PA: Up to 9 doses of 1.0 mg of rt-PA will be administered through the catheter that was placed directly into the intracerebral hemorrhage using minimally invasive surgery.

Subjects randomized to medical management will receive the standard medical therapies for the treatment of intracerebral hemorrhage, which includes ICU care only and no planned surgical intervention.
Overall Number of Participants Analyzed 166 157
Median (Inter-Quartile Range)
Unit of Measure: Days
306
(237 to 329)
300
(232 to 328)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MIS Plus Rt-PA Management, Medical Management
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.78
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
6.Secondary Outcome
Title Patient Disposition: Patient Location at 365 Days Post Ictus (i.e., Good vs. Bad Location) (Adjusted)
Hide Description

Patient disposition: By group comparison of residential location at day 365 post ictus adjusted for baseline severity.

Good locations refers to home and rehabilitation; and bad locations refers to acute care, long-term care and death.

Time Frame Day 365
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title MIS Plus Rt-PA Management Medical Management
Hide Arm/Group Description:

Subjects randomized to the MIS plus rt-PA management arm will undergo minimally invasive surgery followed by up to 9 doses of 1.0 mg of rt-PA (Activase/Alteplase/CathFlo) for intracerebral hemorrhage clot resolution.

rt-PA: Up to 9 doses of 1.0 mg of rt-PA will be administered through the catheter that was placed directly into the intracerebral hemorrhage using minimally invasive surgery.

Subjects randomized to medical management will receive the standard medical therapies for the treatment of intracerebral hemorrhage, which includes ICU care only and no planned surgical intervention.
Overall Number of Participants Analyzed 250 249
Measure Type: Count of Participants
Unit of Measure: Participants
Good Location
163
  65.2%
151
  60.6%
Bad location
87
  34.8%
98
  39.4%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MIS Plus Rt-PA Management, Medical Management
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.34
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 0.04
Confidence Interval (2-Sided) 95%
-0.04 to 0.11
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Dichotomized, Adjudicated, Cross-sectional Modified Rankin Scale (mRS) Score 0-3 vs. 4-6 180 Days Post Ictus (Adjusted)
Hide Description

Dichotomized, adjudicated, cross-sectional modified Rankin Scale (mRS) score 0-3 vs. 4-6 at 180 days post-ictus, adjusting for baseline (pre-randomization) variables used in covariate adaptive randomization as well as the clinically established severity variables IVH size and ICH location (lobar or deep).

The mRS is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. It is scored from: 0=No symptoms at all, 1=No significant disability, 2=Slight disability, 3=Moderate disability, 4=Moderately severe disability, 5=Severe disability and 6=death. Dichotomized scores are: 0-3=No symptoms to moderate disability requiring some assistance; 4-6=Moderately severe disability requiring complete assistance to death

Time Frame Day 180
Hide Outcome Measure Data
Hide Analysis Population Description
Includes patients who were not lost to followup at day 180
Arm/Group Title MIS Plus Rt-PA Management Medical Management
Hide Arm/Group Description:

Subjects randomized to the MIS plus rt-PA management arm will undergo minimally invasive surgery followed by up to 9 doses of 1.0 mg of rt-PA (Activase/Alteplase/CathFlo) for intracerebral hemorrhage clot resolution.

rt-PA: Up to 9 doses of 1.0 mg of rt-PA will be administered through the catheter that was placed directly into the intracerebral hemorrhage using minimally invasive surgery.

Subjects randomized to medical management will receive the standard medical therapies for the treatment of intracerebral hemorrhage, which includes ICU care only and no planned surgical intervention.
Overall Number of Participants Analyzed 250 243
Measure Type: Count of Participants
Unit of Measure: Participants
mRS 0-3
99
  39.6%
93
  38.3%
mRS 4-6
151
  60.4%
150
  61.7%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MIS Plus Rt-PA Management, Medical Management
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.76
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value -0.01
Confidence Interval (2-Sided) 95%
-0.10 to 0.07
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection MIS Plus Rt-PA Management
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.31
Comments [Not Specified]
Method Multivariate logit model
Comments Adjusted for age, GCS, Stability ICH volume, Stability IVH volume, ICH deep location
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.25
Confidence Interval (2-Sided) 95%
0.81 to 1.94
Estimation Comments [Not Specified]
8.Secondary Outcome
Title Dichotomized Extended Glasgow Outcome Scale (eGOS) Score UGR-US vs. LS-Death at 180 Days Post Ictus (Adjusted)
Hide Description

Dichotomized, cross-sectional extended Glasgow Outcome Scale (eGOS) score upper good recovery (UGR) through upper severe disability (US) vs. lower severe disability (LS) through death at 180 days post ictus, adjusting for baseline (pre-randomization) variables used in covariate adaptive randomization as well as the clinically established severity variables IVH size and ICH location (lobar or deep).

The eGOS is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. It is scored as: 1=Death, 2=Vegetative state, 3=Lower severe disability, 4=Upper severe disability, 5=Lower moderate disability, 6=Upper moderate disability, 7=Lower good recovery, 8=Upper good recovery. Dichotomous variable coding is as follows: 1=codes 4-8, 0=codes 1-3.

Time Frame Day 180
Hide Outcome Measure Data
Hide Analysis Population Description
Patients were included if they were not lost to followup at day 180
Arm/Group Title MIS Plus Rt-PA Management Medical Management
Hide Arm/Group Description:

Subjects randomized to the MIS plus rt-PA management arm will undergo minimally invasive surgery followed by up to 9 doses of 1.0 mg of rt-PA (Activase/Alteplase/CathFlo) for intracerebral hemorrhage clot resolution.

rt-PA: Up to 9 doses of 1.0 mg of rt-PA will be administered through the catheter that was placed directly into the intracerebral hemorrhage using minimally invasive surgery.

Subjects randomized to medical management will receive the standard medical therapies for the treatment of intracerebral hemorrhage, which includes ICU care only and no planned surgical intervention.
Overall Number of Participants Analyzed 250 243
Measure Type: Count of Participants
Unit of Measure: Participants
eGOS UGR-US (4-8)
81
  32.4%
76
  31.3%
eGOS LS-Death (1-3)
169
  67.6%
167
  68.7%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MIS Plus Rt-PA Management
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.79
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 0.01
Confidence Interval (2-Sided) 95%
-0.07 to 0.09
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection MIS Plus Rt-PA Management, Medical Management
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.35
Comments [Not Specified]
Method Multivariate logit model
Comments Adjusted for age, GCS, Stability ICH volume, Stability IVH volume, ICH deep location
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.24
Confidence Interval (2-Sided) 95%
0.79 to 1.97
Estimation Comments [Not Specified]
9.Secondary Outcome
Title Type and Intensity of ICU Management: ICU Days
Hide Description By group comparison of cumulative number of days in the Intensive Care Unit (ICU) in a hospital
Time Frame Up to 365 days
Hide Outcome Measure Data
Hide Analysis Population Description
Includes patients with cumulative ICU days during the 365 days of follow-up
Arm/Group Title MIS Plus Rt-PA Management Medical Management
Hide Arm/Group Description:

Subjects randomized to the MIS plus rt-PA management arm will undergo minimally invasive surgery followed by up to 9 doses of 1.0 mg of rt-PA (Activase/Alteplase/CathFlo) for intracerebral hemorrhage clot resolution.

rt-PA: Up to 9 doses of 1.0 mg of rt-PA will be administered through the catheter that was placed directly into the intracerebral hemorrhage using minimally invasive surgery.

Subjects randomized to medical management will receive the standard medical therapies for the treatment of intracerebral hemorrhage, which includes ICU care only and no planned surgical intervention.
Overall Number of Participants Analyzed 240 238
Median (Inter-Quartile Range)
Unit of Measure: Days
10
(7 to 17)
10
(5 to 16)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MIS Plus Rt-PA Management, Medical Management
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.46
Comments [Not Specified]
Method Median test
Comments [Not Specified]
10.Secondary Outcome
Title Type and Intensity of ICU Management: Hospital Days
Hide Description By group comparison of total number of days in the hospital
Time Frame Up to 365 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title MIS Plus Rt-PA Management Medical Management
Hide Arm/Group Description:

Subjects randomized to the MIS plus rt-PA management arm will undergo minimally invasive surgery followed by up to 9 doses of 1.0 mg of rt-PA (Activase/Alteplase/CathFlo) for intracerebral hemorrhage clot resolution.

rt-PA: Up to 9 doses of 1.0 mg of rt-PA will be administered through the catheter that was placed directly into the intracerebral hemorrhage using minimally invasive surgery.

Subjects randomized to medical management will receive the standard medical therapies for the treatment of intracerebral hemorrhage, which includes ICU care only and no planned surgical intervention.
Overall Number of Participants Analyzed 250 249
Median (Inter-Quartile Range)
Unit of Measure: Days
17
(13 to 27)
17
(10 to 25)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MIS Plus Rt-PA Management, Medical Management
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.75
Comments [Not Specified]
Method Median test
Comments [Not Specified]
11.Secondary Outcome
Title EQ-VAS
Hide Description By group comparison of EQ-VAS at day 365 post ictus. The EuroQol Visual Analogue Scale (EQ-VAS) is a self-reported measure of health status. It is a marked scale where subjects draw a line to indicate their health, with end points of 0 (the worst health you can imagine) and 100 (the best health you can imagine).
Time Frame Day 365
Hide Outcome Measure Data
Hide Analysis Population Description
Includes patients who survived or were not lost to followup through 365 days
Arm/Group Title MIS Plus Rt-PA Management Medical Management
Hide Arm/Group Description:

Subjects randomized to the MIS plus rt-PA management arm will undergo minimally invasive surgery followed by up to 9 doses of 1.0 mg of rt-PA (Activase/Alteplase/CathFlo) for intracerebral hemorrhage clot resolution.

rt-PA: Up to 9 doses of 1.0 mg of rt-PA will be administered through the catheter that was placed directly into the intracerebral hemorrhage using minimally invasive surgery.

Subjects randomized to medical management will receive the standard medical therapies for the treatment of intracerebral hemorrhage, which includes ICU care only and no planned surgical intervention.
Overall Number of Participants Analyzed 183 164
Median (Inter-Quartile Range)
Unit of Measure: score on a scale
70
(50 to 80)
70
(50 to 80)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MIS Plus Rt-PA Management, Medical Management
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.66
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
12.Secondary Outcome
Title EuroQol 5 Dimensional Scale (EQ-5D)
Hide Description By group comparison of EQ-5D at day 365 post ictus. The EuroQol 5 Dimensional Scale (Eq-5D) is a self-reported measure of health status. It is arranged to assess domains related to mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. For each domain, codes were 1=no problems, 2=some problems, 3=extreme problems, and 9=unknown. Having a problem in at least 1 domain was coded as 1 (originally represented by 2 or 3) and no problems as 0 (originally represented by 1) .
Time Frame Day 365
Hide Outcome Measure Data
Hide Analysis Population Description
Patients were included if they survived or were not lost to followup through 365 days
Arm/Group Title MIS Plus Rt-PA Management Medical Management
Hide Arm/Group Description:

Subjects randomized to the MIS plus rt-PA management arm will undergo minimally invasive surgery followed by up to 9 doses of 1.0 mg of rt-PA (Activase/Alteplase/CathFlo) for intracerebral hemorrhage clot resolution.

rt-PA: Up to 9 doses of 1.0 mg of rt-PA will be administered through the catheter that was placed directly into the intracerebral hemorrhage using minimally invasive surgery.

Subjects randomized to medical management will receive the standard medical therapies for the treatment of intracerebral hemorrhage, which includes ICU care only and no planned surgical intervention.
Overall Number of Participants Analyzed 192 170
Measure Type: Count of Participants
Unit of Measure: Participants
Any problem
176
  91.7%
155
  91.2%
No problem
16
   8.3%
15
   8.8%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MIS Plus Rt-PA Management, Medical Management
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.87
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
13.Other Pre-specified Outcome
Title Mortality and Safety Events: First-week (Operative) Mortality
Hide Description Mortality and Safety events: By group comparison of mortality within the first 7 days post randomization.
Time Frame Day 7
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title MIS Plus Rt-PA Management Medical Management
Hide Arm/Group Description:

Subjects randomized to the MIS plus rt-PA management arm will undergo minimally invasive surgery followed by up to 9 doses of 1.0 mg of rt-PA (Activase/Alteplase/CathFlo) for intracerebral hemorrhage clot resolution.

rt-PA: Up to 9 doses of 1.0 mg of rt-PA will be administered through the catheter that was placed directly into the intracerebral hemorrhage using minimally invasive surgery.

Subjects randomized to medical management will receive the standard medical therapies for the treatment of intracerebral hemorrhage, which includes ICU care only and no planned surgical intervention.
Overall Number of Participants Analyzed 250 249
Measure Type: Count of Participants
Unit of Measure: Participants
2
   0.8%
10
   4.0%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MIS Plus Rt-PA Management, Medical Management
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.02
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
14.Other Pre-specified Outcome
Title Mortality and Safety Events: All Cause Mortality
Hide Description By group comparison of mortality from all causes within the first 30 days post randomization.
Time Frame Day 30
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title MIS Plus Rt-PA Management Medical Management
Hide Arm/Group Description:

Subjects randomized to the MIS plus rt-PA management arm will undergo minimally invasive surgery followed by up to 9 doses of 1.0 mg of rt-PA (Activase/Alteplase/CathFlo) for intracerebral hemorrhage clot resolution.

rt-PA: Up to 9 doses of 1.0 mg of rt-PA will be administered through the catheter that was placed directly into the intracerebral hemorrhage using minimally invasive surgery.

Subjects randomized to medical management will receive the standard medical therapies for the treatment of intracerebral hemorrhage, which includes ICU care only and no planned surgical intervention.
Overall Number of Participants Analyzed 250 249
Measure Type: Count of Participants
Unit of Measure: Participants
23
   9.2%
37
  14.9%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MIS Plus Rt-PA Management, Medical Management
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.05
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
15.Other Pre-specified Outcome
Title Mortality and Safety Events: Adjudicated Symptomatic Brain Bleeding Within 72 Hours After Last Dose
Hide Description By group comparison of the percentage of subjects experiencing one or more adjudicated symptomatic brain bleeding events within the first 30 days post randomization.
Time Frame 72 hours after last dose
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title MIS Plus Rt-PA Management Medical Management
Hide Arm/Group Description:

Subjects randomized to the MIS plus rt-PA management arm will undergo minimally invasive surgery followed by up to 9 doses of 1.0 mg of rt-PA (Activase/Alteplase/CathFlo) for intracerebral hemorrhage clot resolution.

rt-PA: Up to 9 doses of 1.0 mg of rt-PA will be administered through the catheter that was placed directly into the intracerebral hemorrhage using minimally invasive surgery.

Subjects randomized to medical management will receive the standard medical therapies for the treatment of intracerebral hemorrhage, which includes ICU care only and no planned surgical intervention.
Overall Number of Participants Analyzed 250 249
Measure Type: Count of Participants
Unit of Measure: Participants
6
   2.4%
3
   1.2%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MIS Plus Rt-PA Management, Medical Management
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.32
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
16.Other Pre-specified Outcome
Title Mortality and Safety Events: Adjudicated Bacterial Brain Infection
Hide Description By group comparison of the percentage of subjects experiencing one or more adjudicated brain bacterial infection events within the first 30 days post randomization.
Time Frame Day 30
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title MIS Plus Rt-PA Management Medical Management
Hide Arm/Group Description:

Subjects randomized to the MIS plus rt-PA management arm will undergo minimally invasive surgery followed by up to 9 doses of 1.0 mg of rt-PA (Activase/Alteplase/CathFlo) for intracerebral hemorrhage clot resolution.

rt-PA: Up to 9 doses of 1.0 mg of rt-PA will be administered through the catheter that was placed directly into the intracerebral hemorrhage using minimally invasive surgery.

Subjects randomized to medical management will receive the standard medical therapies for the treatment of intracerebral hemorrhage, which includes ICU care only and no planned surgical intervention.
Overall Number of Participants Analyzed 250 249
Measure Type: Count of Participants
Unit of Measure: Participants
2
   0.8%
0
   0.0%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MIS Plus Rt-PA Management, Medical Management
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.16
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
17.Other Pre-specified Outcome
Title Mortality and Safety Events: Total Serious Adverse Events (SAE) at 30 Days
Hide Description By group comparison of the total number of adjudicated serious adverse events that occurred within the first 30 days post randomization.
Time Frame Day 30
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title MIS Plus Rt-PA Management Medical Management
Hide Arm/Group Description:

Subjects randomized to the MIS plus rt-PA management arm will undergo minimally invasive surgery followed by up to 9 doses of 1.0 mg of rt-PA (Activase/Alteplase/CathFlo) for intracerebral hemorrhage clot resolution.

rt-PA: Up to 9 doses of 1.0 mg of rt-PA will be administered through the catheter that was placed directly into the intracerebral hemorrhage using minimally invasive surgery.

Subjects randomized to medical management will receive the standard medical therapies for the treatment of intracerebral hemorrhage, which includes ICU care only and no planned surgical intervention.
Overall Number of Participants Analyzed 250 249
Measure Type: Number
Unit of Measure: Number of events
123 136
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MIS Plus Rt-PA Management, Medical Management
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.01
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
18.Other Pre-specified Outcome
Title Mortality and Safety Events: Summary of AE and SAE by MedDRA Code and Grouped by Organ System Within the First 30 Days Post Ictus
Hide Description By group comparison of the total number of adjudicated adverse events (AE) and serious adverse events (SAE) across all coded organ systems that occurred within the first 30 days post ictus.
Time Frame Day 30
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title MIS Plus Rt-PA Management Medical Management
Hide Arm/Group Description:

Subjects randomized to the MIS plus rt-PA management arm will undergo minimally invasive surgery followed by up to 9 doses of 1.0 mg of rt-PA (Activase/Alteplase/CathFlo) for intracerebral hemorrhage clot resolution.

rt-PA: Up to 9 doses of 1.0 mg of rt-PA will be administered through the catheter that was placed directly into the intracerebral hemorrhage using minimally invasive surgery.

Subjects randomized to medical management will receive the standard medical therapies for the treatment of intracerebral hemorrhage, which includes ICU care only and no planned surgical intervention.
Overall Number of Participants Analyzed 250 249
Measure Type: Number
Unit of Measure: Number of events
Serious Adverse Events 123 136
Adverse Events 477 378
Time Frame 30 days post-ictus
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title MIS Plus Rt-PA Management Medical Management
Hide Arm/Group Description

Subjects randomized to the MIS plus rt-PA management arm will undergo minimally invasive surgery followed by up to 9 doses of 1.0 mg of rt-PA (Activase/Alteplase/CathFlo) for intracerebral hemorrhage clot resolution.

rt-PA: Up to 9 doses of 1.0 mg of rt-PA will be administered through the catheter that was placed directly into the intracerebral hemorrhage using minimally invasive surgery.

Subjects randomized to medical management will receive the standard medical therapies for the treatment of intracerebral hemorrhage, which includes ICU care only and no planned surgical intervention.
All-Cause Mortality
MIS Plus Rt-PA Management Medical Management
Affected / at Risk (%) Affected / at Risk (%)
Total   48/250 (19.20%)      62/249 (24.90%)    
Hide Serious Adverse Events
MIS Plus Rt-PA Management Medical Management
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   75/250 (30.00%)      84/249 (33.73%)    
Cardiac disorders     
Cardiac disorders  1  3/250 (1.20%)  4 1/249 (0.40%)  2
Gastrointestinal disorders     
Gastrointestinal disorders  1  3/250 (1.20%)  4 4/249 (1.61%)  6
General disorders     
General disorders and administration site conditions  1  13/250 (5.20%)  13 26/249 (10.44%)  27
Infections and infestations     
Non-neurological infections  1  2/250 (0.80%)  5 4/249 (1.61%)  8
Injury, poisoning and procedural complications     
Injury, Poisoning and procedural complications  1  3/250 (1.20%)  3 0/249 (0.00%)  0
Metabolism and nutrition disorders     
Metabolism and nutrition disorders  1  1/250 (0.40%)  1 0/249 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Neoplasms(Benign, malignant or unspecified  1  1/250 (0.40%)  1 0/249 (0.00%)  0
Nervous system disorders     
Nervous system disorders  1  17/250 (6.80%)  41 33/249 (13.25%)  62
Psychiatric disorders     
Psychiatric disorders  1  0/250 (0.00%)  0 1/249 (0.40%)  2
Renal and urinary disorders     
Renal and urinary disorders  1  0/250 (0.00%)  0 1/249 (0.40%)  4
Respiratory, thoracic and mediastinal disorders     
Respiratory, thoracic and mediastinal disirders  1  26/250 (10.40%)  40 14/249 (5.62%)  25
Vascular disorders     
Vascular disorders  1  6/250 (2.40%)  11 0/249 (0.00%)  0
1
Term from vocabulary, MedDRA
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
MIS Plus Rt-PA Management Medical Management
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   205/250 (82.00%)      169/249 (67.87%)    
Blood and lymphatic system disorders     
Blood and lymphatic system disorders  1  2/250 (0.80%)  3 0/249 (0.00%)  0
Cardiac disorders     
Cardiac disorders  1  3/250 (1.20%)  15 5/249 (2.01%)  11
Gastrointestinal disorders     
Gastrointestinal disorders  1  5/250 (2.00%)  12 7/249 (2.81%)  17
General disorders     
General disorders and administration site conditions  1  17/250 (6.80%)  53 12/249 (4.82%)  42
Hepatobiliary disorders     
Hepatobiliary disorders  1  0/250 (0.00%)  0 2/249 (0.80%)  2
Immune system disorders     
Immune system disorders  1  0/250 (0.00%)  0 1/249 (0.40%)  1
Infections and infestations     
Infections, non-neurologic  1  9/250 (3.60%)  16 25/249 (10.04%)  41
Injury, poisoning and procedural complications     
Injury, poisoning and procedural complications  1  1/250 (0.40%)  4 2/249 (0.80%)  3
Investigations     
Investigations  1  1/250 (0.40%)  12 7/249 (2.81%)  20
Metabolism and nutrition disorders     
Metabolism and nutrition disorders  1  3/250 (1.20%)  17 6/249 (2.41%)  20
Musculoskeletal and connective tissue disorders     
Musculoskeletal and connective tissue disorders  1  2/250 (0.80%)  3 0/249 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Neoplasms: benign, malignant, Unspecified (incl cysts and polyps)  1  1/250 (0.40%)  1 1/249 (0.40%)  2
Nervous system disorders     
Nervous system disorders  1  108/250 (43.20%)  216 47/249 (18.88%)  107
Psychiatric disorders     
Psychiatric disorders  1  6/250 (2.40%)  14 5/249 (2.01%)  13
Renal and urinary disorders     
Renal and urinary disorders  1  3/250 (1.20%)  5 2/249 (0.80%)  5
Respiratory, thoracic and mediastinal disorders     
Respiratory, thoracic and mediastinal disorders  1  30/250 (12.00%)  67 33/249 (13.25%)  62
Skin and subcutaneous tissue disorders     
Skin and subcutaneous tissue disorders  1  0/250 (0.00%)  0 1/249 (0.40%)  3
Vascular disorders     
Vascular disorders  1  14/250 (5.60%)  39 13/249 (5.22%)  29
1
Term from vocabulary, MedDRA
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Daniel F. Hanley
Organization: Johns Hopkins University Division of Brain Injury Outcomes
Phone: 4106146996
EMail: dhanley@jhmi.edu
Layout table for additonal information
Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT01827046    
Other Study ID Numbers: NA_00080619
U01NS080824 ( U.S. NIH Grant/Contract )
ICH02 ( Other Identifier: Other )
First Submitted: April 1, 2013
First Posted: April 9, 2013
Results First Submitted: July 23, 2019
Results First Posted: September 27, 2019
Last Update Posted: September 27, 2019