Trial Outcomes & Findings for Fibrinolysis Before Cardiopulmonary Bypass? (NCT NCT01981863)

NCT ID: NCT01981863

Last Updated: 2016-06-30

Results Overview

Change in Di-dimer between preoperative value and value immediately before cardiopulmonary bypass in cardiac surgery patients.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 40 participants
• Primary outcome timeframe: 6 months
• Results posted on: 2016-06-30

Participant Flow

Participant milestones

Measure	Epsilonaminocaproic Acid 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, Antifibrinolytic Activity Placebo: same IV volume as experimental arm Placebo: Placebo administered in same volume as in experimental arm.
Overall Study STARTED	20	20
Overall Study COMPLETED	20	20
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Fibrinolysis Before Cardiopulmonary Bypass?

Baseline characteristics by cohort

Measure	Epsilonaminocaproic Acid n=20 Participants 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, Antifibrinolytic Activity n=20 Participants Placebo: same IV volume as experimental arm Placebo: Placebo administered in same volume as in experimental arm.	Total n=40 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	12 Participants n=5 Participants	10 Participants n=7 Participants	22 Participants n=5 Participants
Age, Categorical >=65 years	8 Participants n=5 Participants	10 Participants n=7 Participants	18 Participants n=5 Participants
Age, Continuous	57 years STANDARD_DEVIATION 17 • n=5 Participants	60 years STANDARD_DEVIATION 15 • n=7 Participants	58 years STANDARD_DEVIATION 16 • n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants	7 Participants n=7 Participants	17 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants	13 Participants n=7 Participants	23 Participants n=5 Participants
Region of Enrollment United States	20 participants n=5 Participants	20 participants n=7 Participants	40 participants n=5 Participants

PRIMARY outcome

Timeframe: 6 months

Population: D-Dimer from preoperative value and value immediately before cardiopulmonary bypass in cardiac surgery patients

Change in Di-dimer between preoperative value and value immediately before cardiopulmonary bypass in cardiac surgery patients.

Outcome measures

Measure	Epsilonaminocaproic Acid n=20 Participants 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, Antifibrinolytic Activity n=20 Participants Placebo: same IV volume as experimental arm Placebo: Placebo administered in same volume as in experimental arm.
Di-Dimer Increase Before Cardiopulmonary Bypass Preoperative Value	317 ng/mL Interval 200.0 to 2862.0	266 ng/mL Interval 200.0 to 1224.0
Di-Dimer Increase Before Cardiopulmonary Bypass Immediately Before Cardiopulmonary Bypass	317 ng/mL Interval 200.0 to 2689.0	291 ng/mL Interval 200.0 to 1206.0
Di-Dimer Increase Before Cardiopulmonary Bypass Post cardiopulmonary bypass	537 ng/mL Interval 200.0 to 3302.0	911 ng/mL Interval 266.0 to 3322.0

SECONDARY outcome

Timeframe: 6 months

Thromboelastography may display if fibrinolysis is present

Outcome measures

Measure	Epsilonaminocaproic Acid n=20 Participants 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, Antifibrinolytic Activity n=20 Participants Placebo: same IV volume as experimental arm Placebo: Placebo administered in same volume as in experimental arm.
Value of Thromboelastography as Monitor of Fibrinolysis Preoperative Estimated Plasma Lysis	0 percentage of clot Interval 0.0 to 100.0	0 percentage of clot Interval 0.0 to 100.0
Value of Thromboelastography as Monitor of Fibrinolysis Estimated Plasma Lysis Prior to Bypass	0 percentage of clot Interval 0.0 to 100.0	0 percentage of clot Interval 0.0 to 100.0
Value of Thromboelastography as Monitor of Fibrinolysis Estimated Plasma Lysis Post Bypass	0 percentage of clot Interval 0.0 to 100.0	0 percentage of clot Interval 0.0 to 100.0

OTHER_PRE_SPECIFIED outcome

Timeframe: From incision to bypass, up to 3 hours

Mean Length of Time from Incision to Cardiopulmonary Bypass

Outcome measures

Measure	Epsilonaminocaproic Acid n=20 Participants 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, Antifibrinolytic Activity n=20 Participants Placebo: same IV volume as experimental arm Placebo: Placebo administered in same volume as in experimental arm.
Length of Time Between Incision and Cardiopulmonary Bypass	140 Minutes Standard Deviation 63	165 Minutes Standard Deviation 63

Adverse Events

Epsilonaminocaproic Acid

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo, Antifibrinolytic Activity

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Peter van der Starre

Stanford University Medical Center

Phone: 6507236412

Email: pieterva@stanford.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place