Trial · NCT02655653

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

NCT02655653, Phase 3, Completed, Montefiore Medical Center; results first posted 2020-06-16

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Efficacy of Tranexamic Acid and Epsilon-aminocaproic Acid in Reducing Bleeding and Transfusions in Cardiac Surgery. Trials, record NCT02655653. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02655653

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Efficacy of Tranexamic Acid and Epsilon-aminocaproic Acid in Reducing Bleeding and Transfusions in Cardiac Surgery
NCT number: NCT02655653
Status: Completed
Phases: Phase 3
Enrollment: 114 participants, actual
Lead sponsor: Montefiore Medical Center
Conditions: Bleeding
Interventions: Epsilon-aminocaproic acid administered, Tranexamic Acid administered
First posted: 2016-01-14
Last updated: 2020-06-16
Results first posted: 2020-06-16

Source ClinicalTrials.gov

Registered outcomes12

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Chest Tube Drainage	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.
Primary	Median Amount of Blood Products Used	24 hours after surgery	Four types of blood products may be given through blood transfusions: whole blood, red blood cells, platelets, and plasma
Secondary	Diagnosis of Renal Dysfunction Post-operation	Within 30 days after surgery	Confirmed diagnosis of renal dysfunction and hospitalization for the same within 30 days after the surgery
Secondary	Diagnosis of Myocardial Infarction Post-operation	Within 30 days after surgery	Confirmed diagnosis of myocardial infraction and hospitalization for the same within 30 days after the surgery
Secondary	Number of Participants Who Have Confirmed Diagnosis of Respiratory Arrest	Within 30 days after surgery	Confirmed diagnosis of respiratory arrest and hospitalization for the same within 30 days after the surgery
Secondary	Number of Participants With Confirmed Diagnosis of Stroke	Within 30 days after surgery	Confirmed diagnosis of stroke and hospitalization for the same within 30 days after the surgery
Secondary	Number of Participants With Confirmed Diagnosis of Seizure	Within 30 days after surgery	Confirmed diagnosis of seizure and hospitalization for the same within 30 days after the surgery
Secondary	Reoperation	Within 30 days after surgery	Confirmed diagnosis of reopeartion and hospitalization for the same within 30 days after the surgery
Secondary	Mortality Within 30 Days Post-operation	Within 30 days after surgery
Other	Patient Demographics	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.

1 to 10 of 12Source ClinicalTrials.gov

See all 12 registered outcomes

Outcomes12

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Units	Measured as
PRIMARY	Chest Tube Drainage	4 hours, 8 hours, 12 hours, 24 hours	mL	MEAN
PRIMARY	Median Amount of Blood Products Used	24 hours after surgery	L	MEDIAN
SECONDARY	Diagnosis of Renal Dysfunction Post-operation	Within 30 days after surgery	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Diagnosis of Myocardial Infarction Post-operation	Within 30 days after surgery	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Number of Participants Who Have Confirmed Diagnosis of Respiratory Arrest	Within 30 days after surgery	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Number of Participants With Confirmed Diagnosis of Stroke	Within 30 days after surgery	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Number of Participants With Confirmed Diagnosis of Seizure	Within 30 days after surgery	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Reoperation	Within 30 days after surgery	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Mortality Within 30 Days Post-operation	Within 30 days after surgery	Participants	COUNT_OF_PARTICIPANTS
OTHER_PRE_SPECIFIED	Patient Demographics	Baseline

1 to 10 of 12Source ClinicalTrials.gov

See all 12 outcomes

Results by group24

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Chest Tube Drainage	Epsilon-aminocaproic Acid (EACA)	4 hr	200	Standard Deviation 375	mL
Chest Tube Drainage	Tranexamic Acid (TA)	4 hr	225	Standard Deviation 400	mL
Chest Tube Drainage	Epsilon-aminocaproic Acid (EACA)	8 hr	375	Standard Deviation 550	mL
Chest Tube Drainage	Tranexamic Acid (TA)	8 hr	400	Standard Deviation 675	mL
Chest Tube Drainage	Epsilon-aminocaproic Acid (EACA)	12 hr	425	Standard Deviation 750	mL
Chest Tube Drainage	Tranexamic Acid (TA)	12 hr	500	Standard Deviation 825	mL
Chest Tube Drainage	Epsilon-aminocaproic Acid (EACA)	24 hr	700	Standard Deviation 1100	mL
Chest Tube Drainage	Tranexamic Acid (TA)	24 hr	800	Standard Deviation 1225	mL
Median Amount of Blood Products Used	Epsilon-aminocaproic Acid (EACA)		.59	Standard Deviation 1.3	L
Median Amount of Blood Products Used	Tranexamic Acid (TA)		1.20	Standard Deviation 2.2	L

1 to 10 of 24Source ClinicalTrials.gov

See all 24 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Epsilon-aminocaproic Acid (EACA)	56
Overall Study	STARTED	Tranexamic Acid (TA)	58
Overall Study	COMPLETED	Epsilon-aminocaproic Acid (EACA)	56
Overall Study	COMPLETED	Tranexamic Acid (TA)	58
Overall Study	NOT COMPLETED	Epsilon-aminocaproic Acid (EACA)	0
Overall Study	NOT COMPLETED	Tranexamic Acid (TA)	0

Source ClinicalTrials.gov

Adverse events12

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
serious	Death	Cardiac disorders	Epsilon-aminocaproic Acid (EACA)	1	56	1
serious	Death	Cardiac disorders	Tranexamic Acid (TA)	1	58	1
serious	Stroke	Nervous system disorders	Epsilon-aminocaproic Acid (EACA)	2	56
serious	Stroke	Nervous system disorders	Tranexamic Acid (TA)	2	58
serious	Renal Dysfunction	Renal and urinary disorders	Epsilon-aminocaproic Acid (EACA)	3	56
serious	Renal Dysfunction	Renal and urinary disorders	Tranexamic Acid (TA)	2	58
serious	Reoperation within 24 hours	Surgical and medical procedures	Epsilon-aminocaproic Acid (EACA)	3	56
serious	Reoperation within 24 hours	Surgical and medical procedures	Tranexamic Acid (TA)	4	58
serious	Seizure	Nervous system disorders	Epsilon-aminocaproic Acid (EACA)	0	56
serious	Seizure	Nervous system disorders	Tranexamic Acid (TA)	0	58

1 to 10 of 12Source ClinicalTrials.gov

See all 12 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Epsilon-aminocaproic Acid (EACA)	1	56
Total, all-cause mortality	Tranexamic Acid (TA)	1	58
Total, other adverse events	Epsilon-aminocaproic Acid (EACA)	0	56
Total, other adverse events	Tranexamic Acid (TA)	0	58
Total, serious adverse events	Epsilon-aminocaproic Acid (EACA)	20	56
Total, serious adverse events	Tranexamic Acid (TA)	14	58

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons9

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Epsilon-aminocaproic Acid (EACA) vs Tranexamic Acid (TA): Diagnosis of Renal Dysfunction Post-operation	Trial comparisons
Epsilon-aminocaproic Acid (EACA) vs Tranexamic Acid (TA): Number of Participants Who Have Confirmed Diagnosis of Respiratory Arrest	Trial comparisons
Epsilon-aminocaproic Acid (EACA) vs Tranexamic Acid (TA): Number of Participants With Confirmed Diagnosis of Seizure	Trial comparisons
Epsilon-aminocaproic Acid (EACA) vs Tranexamic Acid (TA): Diagnosis of Myocardial Infarction Post-operation	Trial comparisons
Epsilon-aminocaproic Acid (EACA) vs Tranexamic Acid (TA): Reoperation	Trial comparisons
Epsilon-aminocaproic Acid (EACA) vs Tranexamic Acid (TA): Number of Participants With Confirmed Diagnosis of Stroke	Trial comparisons
Epsilon-aminocaproic Acid (EACA) vs Tranexamic Acid (TA): Mortality Within 30 Days Post-operation	Trial comparisons
Epsilon-aminocaproic Acid (EACA) vs Tranexamic Acid (TA): deaths from any cause	Trial comparisons
Epsilon-aminocaproic Acid (EACA) vs Tranexamic Acid (TA): serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT02655653

GET https://conductscience.org/api/trials/v1/NCT02655653/results?page=2

API reference For AI assistants