Dose-ranging Study of Tranexamic Acid in Valve Surgery

Chinese Academy of Medical Sciences, Fuwai Hospital

Status: Completed

Conditions: Valvular Heart Surgery; Hemorrhage

Treatments: Drug: Tranexamic Acid

Study type: Interventional

Funder types: Other

Identifiers

NCT01191554

FW2009006

Details and patient eligibility

About

Cardiac surgical procedures account for a large amount of allogeneic transfusion. Tranexamic acid (TA), a synthetic antifibrinolytic drug, has been shown to reduce blood loss and transfusion requirements in cardiac surgery with Cardiopulmonary bypass. There are currently multiple dosing regimens for TA in cardiac surgery. Preliminary dose-response study has shown that low dose of TA would be as hemostatic efficacy as higher dose. Currently, no randomized study focus on TA in primary valve surgery. The aim of this prospective, double-blinded, randomized trial is to compare two dosing regimens of TA during primary valve surgery on perioperative blood loss and allogeneic blood transfusion.

Enrollment: 175 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• valvular disease patients requiring valvular replacement or repair surgery with cardiopulmonary bypass (CPB)

Exclusion criteria

• a history of bleeding disorders
• active chronic hepatitis or cirrhosis
• chronic renal insufficiency (serum creatinine > 2 mg/dl)
• preoperative anemia (Hb < 10 g/dl)
• previous cardiac surgery
• urgent and emergency surgery

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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175 participants in 2 patient groups

High dosage

Experimental group

Description:

A loading dose of 30 mg/kg and a maintenance infusion of 16 mg/kg through out the operation, and 2 mg/kg into the cardiopulmonary bypass (CPB) prime volume.

Treatment:

Drug: Tranexamic Acid

Low dosage

Experimental group

Description:

A loading dose of 10 mg/kg and a maintenance infusion of 1 mg/kg through out the operation, and 1 mg/kg into the cardiopulmonary bypass (CPB) prime volume.

Treatment:

Drug: Tranexamic Acid