Phase 3
N=114
Efficacy of Tranexamic Acid and Epsilon-aminocaproic Acid in Reducing Bleeding and Transfusions in Cardiac Surgery
Bleeding
Bottom Line
View on ClinicalTrials.gov: NCT02655653 ↗Enrolled (actual)
114
Serious AEs
29.8%
Results posted
Jun 2020
Primary outcome: Primary: Chest Tube Drainage — 200; 225; 375; 400 mL
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Epsilon-aminocaproic acid administered (Drug); Tranexamic Acid administered (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Montefiore Medical Center
- Primary completion
- Oct 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Chest Tube Drainage |
200; 225; 375; 400; 425; 500 | — |
| PRIMARY Median Amount of Blood Products Used |
.59; 1.20 | — |
| SECONDARY Diagnosis of Renal Dysfunction Post-operation |
3; 2 | — |
| SECONDARY Diagnosis of Myocardial Infarction Post-operation |
1; 1 | — |
| SECONDARY Number of Participants Who Have Confirmed Diagnosis of Respiratory Arrest |
11; 5 | — |
| SECONDARY Number of Participants With Confirmed Diagnosis of Stroke |
2; 2 | — |
| SECONDARY Number of Participants With Confirmed Diagnosis of Seizure |
0; 0 | — |
| SECONDARY Reoperation |
3; 4 | — |
| SECONDARY Mortality Within 30 Days Post-operation |
1; 1 | — |
Summary
The investigators primary objective is to compare the effectiveness of epsilon-aminocaproic acid (EACA) and tranexamic acid (TA) in reducing bleeding and transfusion in cardiac surgery, with the hypothesis that TA is more effective. The investigators also seek to further examine the clinical benefits and adverse effects profiles of epsilon-aminocaproic acid and tranexamic acid.
Eligibility Criteria
Inclusion Criteria
- Informed consent obtained before any trial-related activities
- Subjects scheduled to undergo cardiac surgery requiring cardiopulmonary bypass
Exclusion Criteria
- Vulnerable patient populations (unable to consent)
- Religious or other prohibitive reason for not receiving blood transfusion
- History of allergy to epsilon-aminocaproic acid or tranexamic acid
- Pregnant or breast-feeding (if applicable)
- The participation in another clinical or device trial that would affect the patient's coagulation profile
- Cardiac or cardiopulmonary transplantation procedure
- Any history of stroke and/or non-coronary thrombotic disorders (DVT, PE)
- Clinical signs consistent with non-coronary thrombotic disease
- Known congenital deficiency of Protein C, Protein S, Antithrombin and homozygous Factor V Leiden
- Known congenital bleeding disorders
- Weight 150 kg
- Acute renal failure or creatinine > 2.0 mg/dL
- Current surgery including any implantable ventricular assist device requiring CPB including ECMO (extracorpeal membrane oxygenation)
- Current surgery including the aortic arch and/or descending thoracic aorta
- Any changes to the planned surgery, which result int he patient not requiring CPB or meeting exclusion criteria
Data sourced from ClinicalTrials.gov (NCT02655653). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.