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To Study the Effect of Early Cooling in Acute Subdural Hematoma Patients (HOPES)

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: NCT02064959
Recruitment Status : Terminated (interim analysis revealed it was futile, we would not reach an answer at N=60.)
First Posted : February 17, 2014
Results First Posted : October 19, 2020
Last Update Posted : October 19, 2020
Sponsor:
Collaborators:
Vivian L. Smith Foundation for Neurologic Research
Zoll Medical Corporation
Information provided by (Responsible Party):
Dong Kim, The University of Texas Health Science Center, Houston

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Treatment
Condition Subdural Hematoma, Traumatic
Intervention Device: Temperature management Zoll Intravascular Temperature Management device
Enrollment 32
Recruitment Details Subjects were randomized and enrolled prior to evacuation of Subdural hematoma
Pre-assignment Details  
Arm/Group Title Normothermia Hypothermia
Hide Arm/Group Description Control, temperature maintained at 37°C treatment group, temperature at 35°C at dura opening then 33°C > 48 hours
Period Title: Overall Study
Started 16 16
Completed 16 16
Not Completed 0 0
Arm/Group Title Normothermia Hypothermia Total
Hide Arm/Group Description Control, temperature maintained at 37 degrees C treatment group, temperature at 35 degrees C at dura opening then 33 degrees C > 48 hours Total of all reporting groups
Overall Number of Baseline Participants 16 16 32
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants 16 participants 32 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
16
 100.0%
14
  87.5%
30
  93.8%
>=65 years
0
   0.0%
2
  12.5%
2
   6.3%
Age, Continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 16 participants 16 participants 32 participants
41.2  (12.7) 46.6  (15.1) 43.9  (14.0)
[1]
Measure Description: under 18 years, between 18 and 65 years and greater than 65 years
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Participants Number Analyzed 16 participants 16 participants 32 participants
Female
2
  12.5%
5
  31.3%
7
  21.9%
Male
14
  87.5%
11
  68.8%
25
  78.1%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants 16 participants 32 participants
Hispanic or Latino
3
  18.8%
4
  25.0%
7
  21.9%
Not Hispanic or Latino
13
  81.3%
11
  68.8%
24
  75.0%
Unknown or Not Reported
0
   0.0%
1
   6.3%
1
   3.1%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants 16 participants 32 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
5
  31.3%
4
  25.0%
9
  28.1%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
1
   6.3%
2
  12.5%
3
   9.4%
White
10
  62.5%
10
  62.5%
20
  62.5%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment   [1] 
Measure Type: Number
Unit of measure:  Participants
 Number Analyzed 16 participants 16 participants 32 participants
United States 12 13 25
Japan 4 3 7
[1]
Measure Analysis Population Description: Two regions enrolled subjects in this study
Subdural hematoma present  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants 16 participants 32 participants
16
 100.0%
16
 100.0%
32
 100.0%
1.Primary Outcome
Title Number of Participants With Favorable Glasgow Outcome Score-Extended (GOS-E) at 6 Months Post Injury
Hide Description Participants were monitored for 6 months after injury, and GOS-E was scored as favorable (moderate disability to good recovery) or unfavorable (severe disability, vegetative state, or death) at 6 months post-injury.
Time Frame 6 months post injury
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Normothermia Hypothermia
Hide Arm/Group Description:
Control, temperature maintained at 37 degrees °C
treatment group, temperature at 35 degrees °C at dura opening then 33 degrees °C > 48 hours
Overall Number of Participants Analyzed 16 16
Measure Type: Count of Participants
Unit of Measure: Participants
4
  25.0%
6
  37.5%
2.Secondary Outcome
Title Safety as Assessed by Number of Adverse Events Reported Per Participant
Hide Description Adverse events were graded according to the USDHHS Common Terminology Criteria for Adverse Events V4.0. Serious adverse events and pre-defined adverse events of interest that historically were known to be of concern with hypothermia treatment were selected to be monitored and reported regardless of grade. These included cardiac arrhythmias, thromboembolic events, pneumonia, bleeding or hemorrhage, intraoperative hemorrhage, infection (culture positive, e.g., blood stream infection, urinary tract infection, ventriculitis), device-related infection, and death. The number of adverse events per participant were compared between groups.
Time Frame 6 months post injury
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Normothermia Hypothermia
Hide Arm/Group Description:
Control, temperature maintained at 37 degrees °C
treatment group, temperature at 35 degrees °C at dura opening then 33 degrees °C > 48 hours
Overall Number of Participants Analyzed 16 16
Median (Inter-Quartile Range)
Unit of Measure: number of adverse events per participant
4.500
(0.250 to 9.000)
4.000
(2.000 to 7.750)
3.Secondary Outcome
Title Intensive Care Unit (ICU) Length of Stay
Hide Description [Not Specified]
Time Frame from ICU admission to ICU discharge (median of about 11 to 13 days)
Hide Outcome Measure Data
Hide Analysis Population Description
Data was not collected for one participant in the normothermia arm.
Arm/Group Title Normothermia Hypothermia
Hide Arm/Group Description:
Control, temperature maintained at 37 degrees °C
treatment group, temperature at 35 degrees °C at dura opening then 33 degrees °C > 48 hours
Overall Number of Participants Analyzed 15 16
Median (Inter-Quartile Range)
Unit of Measure: days
11.390
(7.948 to 32.429)
12.946
(9.234 to 17.719)
4.Secondary Outcome
Title Hospital Length of Stay
Hide Description [Not Specified]
Time Frame from hospital admission to hospital discharge (median of about 18 to 21 days)
Hide Outcome Measure Data
Hide Analysis Population Description
Data was not collected for one participant in the normothermia arm.
Arm/Group Title Normothermia Hypothermia
Hide Arm/Group Description:
Control, temperature maintained at 37 degrees °C
treatment group, temperature at 35 degrees °C at dura opening then 33 degrees °C > 48 hours
Overall Number of Participants Analyzed 15 16
Median (Inter-Quartile Range)
Unit of Measure: days
18.243
(8.165 to 45.840)
20.674
(17.769 to 29.784)
5.Secondary Outcome
Title Incidence of Cortical Spreading Depolarization
Hide Description [Not Specified]
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Data was not collected for this outcome measure.
Arm/Group Title Normothermia Hypothermia
Hide Arm/Group Description:
Control, temperature maintained at 37 degrees °C
treatment group, temperature at 35 degrees °C at dura opening then 33 degrees °C > 48 hours
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame 6 months post injury
Adverse Event Reporting Description Adverse events with a grade of 3 or higher or predefined adverse events of interest(cardiac arrhythmia, thromboembolic event, pneumonia, pulmonary edema,bleeding/hemorrhage,infection(culture positive), device -related infection, Death)
 
Arm/Group Title Normothermia Hypothermia
Hide Arm/Group Description Control, temperature maintained at 37°C treatment group, temperature at 35°C at dura opening then 33°C > 48 hours
All-Cause Mortality
Normothermia Hypothermia
Affected / at Risk (%) Affected / at Risk (%)
Total   5/16 (31.25%)      3/16 (18.75%)    
Hide Serious Adverse Events
Normothermia Hypothermia
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   10/16 (62.50%)      11/16 (68.75%)    
Blood and lymphatic system disorders     
Anemia † 1  6/16 (37.50%)  10 4/16 (25.00%)  10
Elevated white blood cell count † 1  0/16 (0.00%)  0 1/16 (6.25%)  1
Cardiac disorders     
Sinus Bradycardia † 1  1/16 (6.25%)  2 1/16 (6.25%)  2
Tachycardia,agitation † 1  1/16 (6.25%)  1 0/16 (0.00%)  0
Gastrointestinal disorders     
Infection † 1  0/16 (0.00%)  0 2/16 (12.50%)  2
Mesenteric ischemia with lactic acid disorder (elevated) † 1  0/16 (0.00%)  0 1/16 (6.25%)  1
Hepatobiliary disorders     
Cholecystitis, acute † 1  1/16 (6.25%)  1 0/16 (0.00%)  0
Metabolism and nutrition disorders     
Acidosis † 1  0/16 (0.00%)  0 1/16 (6.25%)  1
hyperglycemia † 1  1/16 (6.25%)  1 0/16 (0.00%)  0
Hypermagnesemia † 1  1/16 (6.25%)  5 4/16 (25.00%)  5
Hypernatremia † 1  4/16 (25.00%)  5 1/16 (6.25%)  5
Hypocalcemia † 1  1/16 (6.25%)  1 0/16 (0.00%)  0
Hypokalemia † 1  3/16 (18.75%)  4 1/16 (6.25%)  4
Hypophosphatemia † 1  4/16 (25.00%)  6 2/16 (12.50%)  6
Nervous system disorders     
Death † 1  5/16 (31.25%)  8 3/16 (18.75%)  8
Epidural hematoma † 1  2/16 (12.50%)  2 0/16 (0.00%)  0
hospital readmission,facial droop † 1  0/16 (0.00%)  0 1/16 (6.25%)  1
Hydrocephalus † 1  2/16 (12.50%)  2 0/16 (0.00%)  0
Elevated intracranial pressure † 1  2/16 (12.50%)  2 0/16 (0.00%)  0
Intracranial Hemorrhage † 1  1/16 (6.25%)  1 0/16 (0.00%)  0
Muscle weakness upper limb † 1  0/16 (0.00%)  0 1/16 (6.25%)  1
Neurological worsening † 1  0/16 (0.00%)  0 1/16 (6.25%)  1
Seizure † 1  1/16 (6.25%)  1 0/16 (0.00%)  0
Stroke † 1  5/16 (31.25%)  6 1/16 (6.25%)  6
Swelling and Hemorrhage during surgery † 1  1/16 (6.25%)  1 0/16 (0.00%)  0
Worsening contusion † 1  1/16 (6.25%)  1 0/16 (0.00%)  0
Renal and urinary disorders     
Urinary Tract infection † 1  2/16 (12.50%)  3 1/16 (6.25%)  3
Respiratory, thoracic and mediastinal disorders     
Laryngeal edema † 1  1/16 (6.25%)  1 0/16 (0.00%)  0
Acute respiratory distress syndrome † 1  1/16 (6.25%)  1 0/16 (0.00%)  0
Hospital readmission/chest wall hematoma † 1  1/16 (6.25%)  1 0/16 (0.00%)  0
Pneumonia † 1  4/16 (25.00%)  9 5/16 (31.25%)  9
pneumothorax † 1  1/16 (6.25%)  1 0/16 (0.00%)  0
Sepsis † 1  0/16 (0.00%)  0 1/16 (6.25%)  1
Surgical and medical procedures     
Vascular Access Complication † 1  0/16 (0.00%)  0 1/16 (6.25%)  1
Vascular disorders     
hypotension † 1  0/16 (0.00%)  0 1/16 (6.25%)  1
Thromboembolic event † 1  5/16 (31.25%)  9 4/16 (25.00%)  9
1
Term from vocabulary, CTCAE (4.0)
†
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Normothermia Hypothermia
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   10/16 (62.50%)      12/16 (75.00%)    
Blood and lymphatic system disorders     
Anemia † 1  4/16 (25.00%)  8 4/16 (25.00%)  8
CPK Increased † 1  1/16 (6.25%)  1 0/16 (0.00%)  0
Lymphocyte decreased † 1  1/16 (6.25%)  1 0/16 (0.00%)  0
Cardiac disorders     
Sinus Bradycardia † 1  1/16 (6.25%)  3 2/16 (12.50%)  3
Supraventricular tachycardia † 1  0/16 (0.00%)  0 1/16 (6.25%)  1
Gastrointestinal disorders     
Constipation † 1  0/16 (0.00%)  0 1/16 (6.25%)  1
Diarrhea † 1  0/16 (0.00%)  0 1/16 (6.25%)  1
General disorders     
Fever † 1  1/16 (6.25%)  2 1/16 (6.25%)  2
Hepatobiliary disorders     
Blood Bilirubin increased † 1  1/16 (6.25%)  1 0/16 (0.00%)  0
Liver dysfunction † 1  0/16 (0.00%)  0 1/16 (6.25%)  1
Investigations     
lipase increased † 1  1/16 (6.25%)  1 0/16 (0.00%)  0
Metabolism and nutrition disorders     
Acidosis † 1  0/16 (0.00%)  0 1/16 (6.25%)  1
Alkalosis † 1  1/16 (6.25%)  2 1/16 (6.25%)  2
Hypermagnesemia † 1  1/16 (6.25%)  3 2/16 (12.50%)  3
Hypernatremia † 1  2/16 (12.50%)  4 2/16 (12.50%)  4
Hypokalemia † 1  1/16 (6.25%)  3 2/16 (12.50%)  3
hyponatremia † 1  0/16 (0.00%)  0 1/16 (6.25%)  1
Hypophosphatemia † 1  2/16 (12.50%)  6 4/16 (25.00%)  6
Musculoskeletal and connective tissue disorders     
Wound Infection † 1  0/16 (0.00%)  0 1/16 (6.25%)  1
Nervous system disorders     
Cranioplasty † 1  0/16 (0.00%)  0 1/16 (6.25%)  1
Hydrocephalus † 1  1/16 (6.25%)  1 0/16 (0.00%)  0
seizure † 1  2/16 (12.50%)  4 2/16 (12.50%)  4
Brain abscess † 1  0/16 (0.00%)  0 1/16 (6.25%)  1
Meningitis † 1  0/16 (0.00%)  0 1/16 (6.25%)  1
Neurological worsening † 1  1/16 (6.25%)  1 0/16 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Pneumonia † 1  3/16 (18.75%)  9 6/16 (37.50%)  9
Laryngeal edema † 1  0/16 (0.00%)  0 1/16 (6.25%)  1
Skin and subcutaneous tissue disorders     
Drug eruption † 1  0/16 (0.00%)  0 1/16 (6.25%)  1
scalp wound/infection † 1  0/16 (0.00%)  0 1/16 (6.25%)  1
Wound drainage † 1  0/16 (0.00%)  0 1/16 (6.25%)  1
Surgical and medical procedures     
Replacement of catheter † 1  0/16 (0.00%)  0 1/16 (6.25%)  1
Vascular disorders     
Hypotension † 1  0/16 (0.00%)  0 1/16 (6.25%)  1
Thrombus(superficial) † 1  1/16 (6.25%)  1 0/16 (0.00%)  0
1
Term from vocabulary, CTCAE (4.0)
†
Indicates events were collected by systematic assessment
Early termination leading to small numbers of subjects analyzed.
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: Georgene W. Hergenroeder, Ph.D., Associate Professor
Organization: The University of Texas Health Science Center at Houston
Phone: 713-500-6230
EMail: lisa.h.schmitt@uth.tmc.edu
Layout table for additonal information
Responsible Party: Dong Kim, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT02064959    
Other Study ID Numbers: HSC-MS-12-0762
First Submitted: February 14, 2014
First Posted: February 17, 2014
Results First Submitted: September 21, 2020
Results First Posted: October 19, 2020
Last Update Posted: October 19, 2020