Prospective Trial of Tranexamic Acid in Cardiac Surgery

Phase 4

Completed

• Conditions: C.Surgical Procedure; Cardiac
• Interventions: Drug: Tranexamic Acid

• Registration Number: NCT01998438
• Lead Sponsor: Hongwen Ji

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-09
• Study First Submitted: 2013-11-12
• Study First Submitted QC: 2013-11-24
• Study First Posted: 2013-11-28
• Primary Completion: 2014-09
• Study Completion: 2014-09
• Status Verified: 2016-01
• Results First Submitted: 2016-01-29
• Results First Submitted QC: 2016-01-29
• Last Update Submitted: 2016-01-29
• Results First Posted: 2016-02-26
• Last Update Posted: 2016-02-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 955

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
small dose	Tranexamic Acid	10mg/kg tranexamic acid add in priming fluid, 10mg/kg single shot slowly when incision, followed by 2mg/(kg·h) infusion until the end of surgery
medium dose	Tranexamic Acid	20mg/kg tranexamic acid add in priming fluid, 20mg/kg single shot slowly when incision, followed by 4mg/(kg·h) infusion until the end of surgery
large dose	Tranexamic Acid	30mg/kg tranexamic acid add in priming fluid, 30mg/kg single shot slowly when incision, followed by 6mg/(kg·h) infusion until the end of surgery

Primary Outcome Measures

Name	Time	Method
Postoperative Blood Loss	24hrs postoperatively

Secondary Outcome Measures

Name	Time	Method
Number of Participants Needs Allogenic Transfusion	on the 7th day postoperatively

Trial Locations

Locations (1)

Cardiovascular Institute and Fuwai Hospital, CAMS&PUMC; 🇨🇳 Beijing, Beijing, China