Prospective Trial of Tranexamic Acid in Cardiac Surgery

C.Surgical Procedure; Cardiac Clinical Trial

Official title:

A Randomized Double-blinded Trial to Explore the Optimum Dose of Tranexamic Acid in Cardiopulmonary Bypass Cardiac Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01998438
• Other study ID #: 2011GWH1
• Status: Completed
• Phase: Phase 4
• First received: November 12, 2013
• Last updated: January 29, 2016
• Start date: September 2012
• Est. completion date: September 2014

Study information

• Verified date: January 2016
• Source: Chinese Academy of Medical Sciences, Fuwai Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 955
• Est. completion date: September 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• C.Surgical Procedure; Cardiac

Intervention

Drug:
• Tranexamic Acid
The loading doses were given in 15 minutes when incision.

Locations

Country	Name	City	State
China	Cardiovascular Institute and Fuwai Hospital, CAMS&PUMC	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Hongwen Ji

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Rate of Reexploration for Bleeding		on the 7th day postoperatively	Yes
Primary	Postoperative Blood Loss		24hrs postoperatively	No
Secondary	Number of Participants Needs Allogenic Transfusion		on the 7th day postoperatively	Yes