Phase 4 N=955 Randomized Triple-blind Treatment

Prospective Trial of Tranexamic Acid in Cardiac Surgery

C.Surgical Procedure; Cardiac

Bottom Line

View on ClinicalTrials.gov: NCT01998438 ↗

Enrolled (actual)

955

Serious AEs

11.0%

Results posted

Feb 2016

Primary outcome: Primary: Postoperative Blood Loss — 520; 490; 450 ml

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Tranexamic Acid (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Hongwen Ji
Primary completion: Sep 2014

Outcome Measures

Outcome	Result	p-value
PRIMARY Postoperative Blood Loss	520; 490; 450	—
SECONDARY Number of Participants Needs Allogenic Transfusion	—	—

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.

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

View full record on ClinicalTrials.gov →

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.