Trial Outcomes & Findings for Efficacy of Tranexamic Acid and Epsilon-aminocaproic Acid in Reducing Bleeding and Transfusions in Cardiac Surgery (NCT NCT02655653)

NCT ID: NCT02655653

Last Updated: 2020-06-16

Results Overview

Chest tube drainage are collected from the nursing records, every 4th hourly the amount fluid collected is reported in the collection sheets.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 114 participants
• Primary outcome timeframe: 4 hours, 8 hours, 12 hours, 24 hours
• Results posted on: 2020-06-16

Participant Flow

Participant milestones

Measure	Epsilon-aminocaproic Acid (EACA) Epsilon-aminocaproic acid administered following anesthetic induction: EACA was administered as a bolus loading dose of 150 mg/ kg followed by a maintenance infusion of 15 mg/ kg /hr. Epsilon-aminocaproic acid administered: Following anesthetic induction, Epsilon-aminocaproic acid was administered as a bolus loading dose of 150 mg/ kg followed by a maintenance infusion of 15 mg/ kg /hr. Maintenance infusion of both drugs was discontinued when the patient arrived in the cardiac surgical intensive care unit. In addition to routine blood sampling ( standard of care in our hospital), patients had thromboelastogram(TEG) and D-dimer levels drawn at the following time points: post incision but prior to initial antifibrinolytic load, immediately following the antifibrinolytic loading dose, and post-protamine reversal of heparin.	Tranexamic Acid (TA) Tranexamic Acid administered following induction: TA was administered as a bolus dose of 30 mg /kg followed by a 16 mg/ kg/hour maintenance infusion. Tranexamic Acid administered: Following anesthetic induction, Tranexamic Acid was administered as a bolus dose of 30 mg /kg followed by a 16 mg/ kg/hour maintenance infusion. Maintenance infusion of both drugs was discontinued when the patient arrived in the cardiac surgical intensive care unit. In addition to routine blood sampling ( standard of care in our hospital), patients had thromboelastogram(TEG) and D-dimer levels drawn at the following time points: post incision but prior to initial antifibrinolytic load, immediately following the antifibrinolytic loading dose, and post-protamine reversal of heparin.
Overall Study STARTED	56	58
Overall Study COMPLETED	56	58
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Efficacy of Tranexamic Acid and Epsilon-aminocaproic Acid in Reducing Bleeding and Transfusions in Cardiac Surgery

Baseline characteristics by cohort

Measure	Epsilon-aminocaproic Acid (EACA) n=56 Participants Epsilon-aminocaproic acid administered following anesthetic induction: EACA was administered as a bolus loading dose of 150 mg/ kg followed by a maintenance infusion of 15 mg/ kg /hr. Epsilon-aminocaproic acid administered: Following anesthetic induction, Epsilon-aminocaproic acid was administered as a bolus loading dose of 150 mg/ kg followed by a maintenance infusion of 15 mg/ kg /hr. Maintenance infusion of both drugs was discontinued when the patient arrived in the cardiac surgical intensive care unit. In addition to routine blood sampling ( standard of care in our hospital), patients had thromboelastogram(TEG) and D-dimer levels drawn at the following time points: post incision but prior to initial antifibrinolytic load, immediately following the antifibrinolytic loading dose, and post-protamine reversal of heparin.	Tranexamic Acid (TA) n=58 Participants Tranexamic Acid administered following induction: TA was administered as a bolus dose of 30 mg /kg followed by a 16 mg/ kg/hour maintenance infusion. Tranexamic Acid administered: Following anesthetic induction, Tranexamic Acid was administered as a bolus dose of 30 mg /kg followed by a 16 mg/ kg/hour maintenance infusion. Maintenance infusion of both drugs was discontinued when the patient arrived in the cardiac surgical intensive care unit. In addition to routine blood sampling ( standard of care in our hospital), patients had thromboelastogram(TEG) and D-dimer levels drawn at the following time points: post incision but prior to initial antifibrinolytic load, immediately following the antifibrinolytic loading dose, and post-protamine reversal of heparin.	Total n=114 Participants Total of all reporting groups
Age, Continuous	64 years n=5 Participants	65 years n=7 Participants	64 years n=5 Participants
Sex/Gender, Customized Female	19 Participants n=5 Participants	28 Participants n=7 Participants	47 Participants n=5 Participants
Sex/Gender, Customized Male	37 Participants n=5 Participants	30 Participants n=7 Participants	67 Participants n=5 Participants
Region of Enrollment United States	56 Participants n=5 Participants	58 Participants n=7 Participants	114 Participants n=5 Participants

PRIMARY outcome

Timeframe: 4 hours, 8 hours, 12 hours, 24 hours

Chest tube drainage are collected from the nursing records, every 4th hourly the amount fluid collected is reported in the collection sheets.

Outcome measures

Measure	Tranexamic Acid (TA) n=58 Participants Tranexamic Acid administered following induction: TA was administered as a bolus dose of 30 mg /kg followed by a 16 mg/ kg/hour maintenance infusion. Tranexamic Acid administered: Following anesthetic induction, Tranexamic Acid was administered as a bolus dose of 30 mg /kg followed by a 16 mg/ kg/hour maintenance infusion. Maintenance infusion of both drugs was discontinued when the patient arrived in the cardiac surgical intensive care unit. In addition to routine blood sampling ( standard of care in our hospital), patients had thromboelastogram(TEG) and D-dimer levels drawn at the following time points: post incision but prior to initial antifibrinolytic load, immediately following the antifibrinolytic loading dose, and post-protamine reversal of heparin.	Epsilon-aminocaproic Acid (EACA) n=56 Participants How many subjects had a myocardial infarction?
Chest Tube Drainage 4 hr	225 mL Standard Deviation 400	200 mL Standard Deviation 375
Chest Tube Drainage 8 hr	400 mL Standard Deviation 675	375 mL Standard Deviation 550
Chest Tube Drainage 12 hr	500 mL Standard Deviation 825	425 mL Standard Deviation 750
Chest Tube Drainage 24 hr	800 mL Standard Deviation 1225	700 mL Standard Deviation 1100

PRIMARY outcome

Timeframe: 24 hours after surgery

Four types of blood products may be given through blood transfusions: whole blood, red blood cells, platelets, and plasma

Outcome measures

Measure	Tranexamic Acid (TA) n=58 Participants Tranexamic Acid administered following induction: TA was administered as a bolus dose of 30 mg /kg followed by a 16 mg/ kg/hour maintenance infusion. Tranexamic Acid administered: Following anesthetic induction, Tranexamic Acid was administered as a bolus dose of 30 mg /kg followed by a 16 mg/ kg/hour maintenance infusion. Maintenance infusion of both drugs was discontinued when the patient arrived in the cardiac surgical intensive care unit. In addition to routine blood sampling ( standard of care in our hospital), patients had thromboelastogram(TEG) and D-dimer levels drawn at the following time points: post incision but prior to initial antifibrinolytic load, immediately following the antifibrinolytic loading dose, and post-protamine reversal of heparin.	Epsilon-aminocaproic Acid (EACA) n=56 Participants How many subjects had a myocardial infarction?
Median Amount of Blood Products Used	1.20 L Standard Deviation 2.2	.59 L Standard Deviation 1.3

SECONDARY outcome

Timeframe: Within 30 days after surgery

Confirmed diagnosis of renal dysfunction and hospitalization for the same within 30 days after the surgery

Outcome measures

Measure	Tranexamic Acid (TA) n=58 Participants Tranexamic Acid administered following induction: TA was administered as a bolus dose of 30 mg /kg followed by a 16 mg/ kg/hour maintenance infusion. Tranexamic Acid administered: Following anesthetic induction, Tranexamic Acid was administered as a bolus dose of 30 mg /kg followed by a 16 mg/ kg/hour maintenance infusion. Maintenance infusion of both drugs was discontinued when the patient arrived in the cardiac surgical intensive care unit. In addition to routine blood sampling ( standard of care in our hospital), patients had thromboelastogram(TEG) and D-dimer levels drawn at the following time points: post incision but prior to initial antifibrinolytic load, immediately following the antifibrinolytic loading dose, and post-protamine reversal of heparin.	Epsilon-aminocaproic Acid (EACA) n=56 Participants How many subjects had a myocardial infarction?
Diagnosis of Renal Dysfunction Post-operation	2 Participants	3 Participants

SECONDARY outcome

Timeframe: Within 30 days after surgery

Confirmed diagnosis of myocardial infraction and hospitalization for the same within 30 days after the surgery

Outcome measures

Measure	Tranexamic Acid (TA) n=58 Participants Tranexamic Acid administered following induction: TA was administered as a bolus dose of 30 mg /kg followed by a 16 mg/ kg/hour maintenance infusion. Tranexamic Acid administered: Following anesthetic induction, Tranexamic Acid was administered as a bolus dose of 30 mg /kg followed by a 16 mg/ kg/hour maintenance infusion. Maintenance infusion of both drugs was discontinued when the patient arrived in the cardiac surgical intensive care unit. In addition to routine blood sampling ( standard of care in our hospital), patients had thromboelastogram(TEG) and D-dimer levels drawn at the following time points: post incision but prior to initial antifibrinolytic load, immediately following the antifibrinolytic loading dose, and post-protamine reversal of heparin.	Epsilon-aminocaproic Acid (EACA) n=56 Participants How many subjects had a myocardial infarction?
Diagnosis of Myocardial Infarction Post-operation	1 Participants	1 Participants

SECONDARY outcome

Timeframe: Within 30 days after surgery

Confirmed diagnosis of respiratory arrest and hospitalization for the same within 30 days after the surgery

Outcome measures

Measure	Tranexamic Acid (TA) n=58 Participants Tranexamic Acid administered following induction: TA was administered as a bolus dose of 30 mg /kg followed by a 16 mg/ kg/hour maintenance infusion. Tranexamic Acid administered: Following anesthetic induction, Tranexamic Acid was administered as a bolus dose of 30 mg /kg followed by a 16 mg/ kg/hour maintenance infusion. Maintenance infusion of both drugs was discontinued when the patient arrived in the cardiac surgical intensive care unit. In addition to routine blood sampling ( standard of care in our hospital), patients had thromboelastogram(TEG) and D-dimer levels drawn at the following time points: post incision but prior to initial antifibrinolytic load, immediately following the antifibrinolytic loading dose, and post-protamine reversal of heparin.	Epsilon-aminocaproic Acid (EACA) n=56 Participants How many subjects had a myocardial infarction?
Number of Participants Who Have Confirmed Diagnosis of Respiratory Arrest	5 Participants	11 Participants

SECONDARY outcome

Timeframe: Within 30 days after surgery

Confirmed diagnosis of stroke and hospitalization for the same within 30 days after the surgery

Outcome measures

Measure	Tranexamic Acid (TA) n=58 Participants Tranexamic Acid administered following induction: TA was administered as a bolus dose of 30 mg /kg followed by a 16 mg/ kg/hour maintenance infusion. Tranexamic Acid administered: Following anesthetic induction, Tranexamic Acid was administered as a bolus dose of 30 mg /kg followed by a 16 mg/ kg/hour maintenance infusion. Maintenance infusion of both drugs was discontinued when the patient arrived in the cardiac surgical intensive care unit. In addition to routine blood sampling ( standard of care in our hospital), patients had thromboelastogram(TEG) and D-dimer levels drawn at the following time points: post incision but prior to initial antifibrinolytic load, immediately following the antifibrinolytic loading dose, and post-protamine reversal of heparin.	Epsilon-aminocaproic Acid (EACA) n=56 Participants How many subjects had a myocardial infarction?
Number of Participants With Confirmed Diagnosis of Stroke	2 Participants	2 Participants

SECONDARY outcome

Timeframe: Within 30 days after surgery

Confirmed diagnosis of seizure and hospitalization for the same within 30 days after the surgery

Outcome measures

Measure	Tranexamic Acid (TA) n=58 Participants Tranexamic Acid administered following induction: TA was administered as a bolus dose of 30 mg /kg followed by a 16 mg/ kg/hour maintenance infusion. Tranexamic Acid administered: Following anesthetic induction, Tranexamic Acid was administered as a bolus dose of 30 mg /kg followed by a 16 mg/ kg/hour maintenance infusion. Maintenance infusion of both drugs was discontinued when the patient arrived in the cardiac surgical intensive care unit. In addition to routine blood sampling ( standard of care in our hospital), patients had thromboelastogram(TEG) and D-dimer levels drawn at the following time points: post incision but prior to initial antifibrinolytic load, immediately following the antifibrinolytic loading dose, and post-protamine reversal of heparin.	Epsilon-aminocaproic Acid (EACA) n=56 Participants How many subjects had a myocardial infarction?
Number of Participants With Confirmed Diagnosis of Seizure	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Within 30 days after surgery

Confirmed diagnosis of reopeartion and hospitalization for the same within 30 days after the surgery

Outcome measures

Measure	Tranexamic Acid (TA) n=58 Participants Tranexamic Acid administered following induction: TA was administered as a bolus dose of 30 mg /kg followed by a 16 mg/ kg/hour maintenance infusion. Tranexamic Acid administered: Following anesthetic induction, Tranexamic Acid was administered as a bolus dose of 30 mg /kg followed by a 16 mg/ kg/hour maintenance infusion. Maintenance infusion of both drugs was discontinued when the patient arrived in the cardiac surgical intensive care unit. In addition to routine blood sampling ( standard of care in our hospital), patients had thromboelastogram(TEG) and D-dimer levels drawn at the following time points: post incision but prior to initial antifibrinolytic load, immediately following the antifibrinolytic loading dose, and post-protamine reversal of heparin.	Epsilon-aminocaproic Acid (EACA) n=56 Participants How many subjects had a myocardial infarction?
Reoperation	4 Participants	3 Participants

SECONDARY outcome

Timeframe: Within 30 days after surgery

Outcome measures

Measure	Tranexamic Acid (TA) n=58 Participants Tranexamic Acid administered following induction: TA was administered as a bolus dose of 30 mg /kg followed by a 16 mg/ kg/hour maintenance infusion. Tranexamic Acid administered: Following anesthetic induction, Tranexamic Acid was administered as a bolus dose of 30 mg /kg followed by a 16 mg/ kg/hour maintenance infusion. Maintenance infusion of both drugs was discontinued when the patient arrived in the cardiac surgical intensive care unit. In addition to routine blood sampling ( standard of care in our hospital), patients had thromboelastogram(TEG) and D-dimer levels drawn at the following time points: post incision but prior to initial antifibrinolytic load, immediately following the antifibrinolytic loading dose, and post-protamine reversal of heparin.	Epsilon-aminocaproic Acid (EACA) n=56 Participants How many subjects had a myocardial infarction?
Mortality Within 30 Days Post-operation	1 Participants	1 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline

Measurements taken as a composite. BMI, Sex, Age are to be determined to ensure that the subjects' characteristics were comparable between the Epsilon-aminocaproic Acid and Tranexamic Acid groups.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Intraoperative

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Intraoperative

Measurements are taken as a composite to determine that the subjects' characteristics are comparable between the Epsilon-aminocaproic Acid and Tranexamic Acid groups. Measurements include temperature, Heparin dose, protamine given, time of surgery, time of cardiopulmonary bypass, and aortic clamp time.

Outcome measures

Outcome data not reported

Adverse Events

Epsilon-aminocaproic Acid (EACA)

Serious events: 20 serious events

Other events: 0 other events

Deaths: 1 deaths

Tranexamic Acid (TA)

Serious events: 14 serious events

Other events: 0 other events

Deaths: 1 deaths

Serious adverse events

Measure	Epsilon-aminocaproic Acid (EACA) n=56 participants at risk Epsilon-aminocaproic acid administered following anesthetic induction: EACA was administered as a bolus loading dose of 150 mg/ kg followed by a maintenance infusion of 15 mg/ kg /hr. Epsilon-aminocaproic acid administered: Following anesthetic induction, Epsilon-aminocaproic acid was administered as a bolus loading dose of 150 mg/ kg followed by a maintenance infusion of 15 mg/ kg /hr. Maintenance infusion of both drugs was discontinued when the patient arrived in the cardiac surgical intensive care unit. In addition to routine blood sampling ( standard of care in our hospital), patients had thromboelastogram(TEG) and D-dimer levels drawn at the following time points: post incision but prior to initial antifibrinolytic load, immediately following the antifibrinolytic loading dose, and post-protamine reversal of heparin.	Tranexamic Acid (TA) n=58 participants at risk Tranexamic Acid administered following induction: TA was administered as a bolus dose of 30 mg /kg followed by a 16 mg/ kg/hour maintenance infusion. Tranexamic Acid administered: Following anesthetic induction, Tranexamic Acid was administered as a bolus dose of 30 mg /kg followed by a 16 mg/ kg/hour maintenance infusion. Maintenance infusion of both drugs was discontinued when the patient arrived in the cardiac surgical intensive care unit. In addition to routine blood sampling ( standard of care in our hospital), patients had thromboelastogram(TEG) and D-dimer levels drawn at the following time points: post incision but prior to initial antifibrinolytic load, immediately following the antifibrinolytic loading dose, and post-protamine reversal of heparin.
Cardiac disorders Death	1.8% 1/56 • Number of events 1	1.7% 1/58 • Number of events 1
Nervous system disorders Stroke	3.6% 2/56	3.4% 2/58
Renal and urinary disorders Renal Dysfunction	5.4% 3/56	3.4% 2/58
Surgical and medical procedures Reoperation within 24 hours	5.4% 3/56	6.9% 4/58
Nervous system disorders Seizure	0.00% 0/56	0.00% 0/58
Respiratory, thoracic and mediastinal disorders Respiratory Arrest	19.6% 11/56	8.6% 5/58

Other adverse events

Adverse event data not reported

Additional Information

Dr. Jonathan Leff

Montefiore Medical Centr

Phone: 7189205409

Email: jleff@montefiore.org

Results disclosure agreements

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