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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01998438
Other study ID # 2011GWH1
Secondary ID
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


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
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