Prospective Trial of Tranexamic Acid in Cardiac Surgery

Hongwen Ji

Status and phase: Completed; Phase 4

Conditions: C.Surgical Procedure; Cardiac

Treatments: Drug: Tranexamic Acid

Study type: Interventional

Funder types: Other

Identifiers

NCT01998438

2011GWH1

Details and patient eligibility

About

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.

Enrollment: 955 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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955 participants in 3 patient groups

small dose

Experimental group

Description:

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

Treatment:

Drug: Tranexamic Acid

medium dose

Experimental group

Description:

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

Treatment:

Drug: Tranexamic Acid

large dose

Experimental group

Description:

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

Treatment:

Drug: Tranexamic Acid