Phase 4
Completed N=955
Prospective Trial of Tranexamic Acid in Cardiac Surgery
C.Surgical Procedure; Cardiac
Source: ClinicalTrials.gov NCT01998438 ↗
Enrolled (actual)
955
Serious AEs
11.0%
Results posted
Feb 2016
Primary outcomePrimary: Postoperative Blood Loss — 520; 490; 450 ml
Summary
Tranexamic acid, an antifibrinolytic drug, is wildly used in cardiac surgeries to decrease perioperative bleeding and allogenic transfusion. But the optimum dose of tranexamic acid is still unknown. We use three different doses to find which is the optimum dose of tranexamic acid in cardiopulmonary bypass cardiac surgery.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Postoperative Blood Loss |
520; 490; 450 | — |
| SECONDARY Number of Participants Needs Allogenic Transfusion |
— | — |
Eligibility Criteria
Inclusion Criteria
- Noncyanotic congenital heart disease patients requiring cardiac surgeries under cardiopulmonary bypass
- Rheumatic or recessive valvular disease patients requiring valvular repair or replacement under cardiopulmonary bypass
- Coronary artery disease patients requiring coronary artery bypass graft under cardiopulmonary bypass
Exclusion Criteria
- Non-primary and emergency cardiac surgery
- Disorder in coagulation function before surgery
- Anemia before surgery
- Definite liver and renal dysfunction
- History of stroke
- Pregnancy and lactation
- Disabled in spirit or law
- Fatal conditions such as cancer
Data sourced from ClinicalTrials.gov (NCT01998438). 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. Informational only — not medical advice.