Comparison · NCT02655653-sae
Epsilon-aminocaproic Acid (EACA) vs Tranexamic Acid (TA): serious adverse events
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
Cite this record
ConductScience Library. Epsilon-aminocaproic Acid (EACA) vs Tranexamic Acid (TA): serious adverse events. Trial comparisons, record NCT02655653-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02655653-sae
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Measures6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note |
|---|---|---|---|---|---|
| Risk in group 1 | 0.357 | 0.245 | 0.488 | wilson | |
| Risk in group 2 | 0.241 | 0.15 | 0.365 | wilson | |
| Risk difference, group 1 minus group 2 | 0.116 | -0.0517 | 0.276 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.48 | 0.832 | 2.63 | log | |
| Odds ratio, group 1 over group 2 | 1.75 | 0.775 | 3.94 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Epsilon-aminocaproic Acid (EACA) than on Tranexamic Acid (TA) | 8.64 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | 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. | 20 | 56 | EG000 |
| Group 2 | 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. | 14 | 58 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
Source ClinicalTrials.gov
Trial
- Title
- Efficacy of Tranexamic Acid and Epsilon-aminocaproic Acid in Reducing Bleeding and Transfusions in Cardiac Surgery
- NCT number
- NCT02655653
- Phases
- PHASE3
- Conditions
- Bleeding
- Interventions
- Epsilon-aminocaproic acid administered, Tranexamic Acid administered
- Lead sponsor
- Montefiore Medical Center
- Results first posted
- 2020-06-16
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02655653?tab=results
Source ClinicalTrials.gov
Source
- Release
- trial-comparisons-2026-03-23-0.1.0
- Release manifest SHA-256
- f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
- AACT copy
- 2026-03-23
- Tables read
- outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet
Source ClinicalTrials.gov
Sources 2
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
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
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.
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