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Trial record 20 of 36 for:    AMINOCAPROIC ACID

Fibrinolysis Before Cardiopulmonary Bypass?

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ClinicalTrials.gov Identifier: NCT01981863
Recruitment Status : Completed
First Posted : November 13, 2013
Results First Posted : June 30, 2016
Last Update Posted : June 30, 2016
Sponsor:
Information provided by (Responsible Party):
Stanford University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Condition Pathologic Fibrinolysis
Interventions Drug: Epsilonaminocaproic acid
Drug: Placebo
Enrollment 40
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Epsilonaminocaproic Acid Placebo, Antifibrinolytic Activity
Hide Arm/Group Description

One arm: Epsilonaminocaproic acid 10 gr IV, followed by 1 gr/hr infusion Second arm: placebo

Epsilonaminocaproic acid: One group receives Epsilonaminocaproic acid, 10 gr IV bolus, followed by 1 gr/hr. Second group receives placebo.

Placebo: same IV volume as experimental arm

Placebo: Placebo administered in same volume as in experimental arm.

Period Title: Overall Study
Started 20 20
Completed 20 20
Not Completed 0 0
Arm/Group Title Epsilonaminocaproic Acid Placebo, Antifibrinolytic Activity Total
Hide Arm/Group Description

One arm: Epsilonaminocaproic acid 10 gr IV, followed by 1 gr/hr infusion Second arm: placebo

Epsilonaminocaproic acid: One group receives Epsilonaminocaproic acid, 10 gr IV bolus, followed by 1 gr/hr. Second group receives placebo.

Placebo: same IV volume as experimental arm

Placebo: Placebo administered in same volume as in experimental arm.

Total of all reporting groups
Overall Number of Baseline Participants 20 20 40
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 20 participants 40 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
12
  60.0%
10
  50.0%
22
  55.0%
>=65 years
8
  40.0%
10
  50.0%
18
  45.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 20 participants 20 participants 40 participants
57  (17) 60  (15) 58  (16)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 20 participants 40 participants
Female
10
  50.0%
7
  35.0%
17
  42.5%
Male
10
  50.0%
13
  65.0%
23
  57.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 20 participants 20 participants 40 participants
20 20 40
1.Primary Outcome
Title Di-Dimer Increase Before Cardiopulmonary Bypass
Hide Description Change in Di-dimer between preoperative value and value immediately before cardiopulmonary bypass in cardiac surgery patients.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
D-Dimer from preoperative value and value immediately before cardiopulmonary bypass in cardiac surgery patients
Arm/Group Title Epsilonaminocaproic Acid Placebo, Antifibrinolytic Activity
Hide Arm/Group Description:

One arm: Epsilonaminocaproic acid 10 gr IV, followed by 1 gr/hr infusion Second arm: placebo

Epsilonaminocaproic acid: One group receives Epsilonaminocaproic acid, 10 gr IV bolus, followed by 1 gr/hr. Second group receives placebo.

Placebo: same IV volume as experimental arm

Placebo: Placebo administered in same volume as in experimental arm.

Overall Number of Participants Analyzed 20 20
Median (Full Range)
Unit of Measure: ng/mL
Preoperative Value
317
(200 to 2862)
266
(200 to 1224)
Immediately Before Cardiopulmonary Bypass
317
(200 to 2689)
291
(200 to 1206)
Post cardiopulmonary bypass
537
(200 to 3302)
911
(266 to 3322)
2.Secondary Outcome
Title Value of Thromboelastography as Monitor of Fibrinolysis
Hide Description Thromboelastography may display if fibrinolysis is present
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Epsilonaminocaproic Acid Placebo, Antifibrinolytic Activity
Hide Arm/Group Description:

One arm: Epsilonaminocaproic acid 10 gr IV, followed by 1 gr/hr infusion Second arm: placebo

Epsilonaminocaproic acid: One group receives Epsilonaminocaproic acid, 10 gr IV bolus, followed by 1 gr/hr. Second group receives placebo.

Placebo: same IV volume as experimental arm

Placebo: Placebo administered in same volume as in experimental arm.

Overall Number of Participants Analyzed 20 20
Median (Full Range)
Unit of Measure: percentage of clot
Preoperative Estimated Plasma Lysis
0
(0 to 100)
0
(0 to 100)
Estimated Plasma Lysis Prior to Bypass
0
(0 to 100)
0
(0 to 100)
Estimated Plasma Lysis Post Bypass
0
(0 to 100)
0
(0 to 100)
3.Other Pre-specified Outcome
Title Length of Time Between Incision and Cardiopulmonary Bypass
Hide Description Mean Length of Time from Incision to Cardiopulmonary Bypass
Time Frame From incision to bypass, up to 3 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Epsilonaminocaproic Acid Placebo, Antifibrinolytic Activity
Hide Arm/Group Description:

One arm: Epsilonaminocaproic acid 10 gr IV, followed by 1 gr/hr infusion Second arm: placebo

Epsilonaminocaproic acid: One group receives Epsilonaminocaproic acid, 10 gr IV bolus, followed by 1 gr/hr. Second group receives placebo.

Placebo: same IV volume as experimental arm

Placebo: Placebo administered in same volume as in experimental arm.

Overall Number of Participants Analyzed 20 20
Mean (Standard Deviation)
Unit of Measure: Minutes
140  (63) 165  (63)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Epsilonaminocaproic Acid, Placebo, Antifibrinolytic Activity
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.21
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Time Frame Intraoperatively: From Induction to Post-Protamine administration, up to 12 hours
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Epsilonaminocaproic Acid Placebo, Antifibrinolytic Activity
Hide Arm/Group Description

One arm: Epsilonaminocaproic acid 10 gr IV, followed by 1 gr/hr infusion Second arm: placebo

Epsilonaminocaproic acid: One group receives Epsilonaminocaproic acid, 10 gr IV bolus, followed by 1 gr/hr. Second group receives placebo.

No adverse advents to report.

Placebo: same IV volume as experimental arm

Placebo: Placebo administered in same volume as in experimental arm.

No adverse events to report.

All-Cause Mortality
Epsilonaminocaproic Acid Placebo, Antifibrinolytic Activity
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Epsilonaminocaproic Acid Placebo, Antifibrinolytic Activity
Affected / at Risk (%) Affected / at Risk (%)
Total   0/20 (0.00%)   0/20 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Epsilonaminocaproic Acid Placebo, Antifibrinolytic Activity
Affected / at Risk (%) Affected / at Risk (%)
Total   0/20 (0.00%)   0/20 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Peter van der Starre
Organization: Stanford University Medical Center
Phone: 6507236412
EMail: pieterva@stanford.edu
Layout table for additonal information
Responsible Party: Stanford University
ClinicalTrials.gov Identifier: NCT01981863     History of Changes
Other Study ID Numbers: Fibrinolysis
First Submitted: September 19, 2013
First Posted: November 13, 2013
Results First Submitted: April 1, 2016
Results First Posted: June 30, 2016
Last Update Posted: June 30, 2016