Three Dose Regimen of Tranexamic Acid in Cardiac Surgery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

600 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-02-28

Study Completion Date

2019-12-31

Brief Summary

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Tranexamic acid is thought to be a promising substitute for aprotinin when the latter has seceded in 2007. Yet the ideal dosage and dosing regimen of tranexamic acid in cardiopulmonary bypass cardiac surgery in Chinese population remains controversial. The current study includes patients receiving valvular replacement and coronary artery bypass surgery. Three dosage regimen of tranexamic acid is delivered and blood loss, transfusions and clinical outcomes are recorded.

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Detailed Description

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Conditions

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Hemostasis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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High dosage

Tranexamic acid with a loading dose of 30 mg/kg and a maintenance infusion of 20 mg/kg/h

Group Type EXPERIMENTAL

Tranexamic Acid

Intervention Type DRUG

Medium dosage

Tranexamic acid with a loading dose of 20 mg/kg and a maintenance infusion of 15 mg/kg/h

Group Type EXPERIMENTAL

Tranexamic Acid

Intervention Type DRUG

Low dosage

Tranexamic acid with a loading dose of 10 mg/kg and a maintenance infusion of 10 mg/kg/h

Group Type EXPERIMENTAL

Tranexamic Acid

Intervention Type DRUG

Control

Saline solution

Group Type PLACEBO_COMPARATOR

Saline Solution

Intervention Type DRUG

Interventions

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Tranexamic Acid

Intervention Type DRUG

Saline Solution

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Rheumatic or recessive valvular disease patients requiring valvular replacement surgery with cardiopulmonary bypass
* Coronary artery disease patients requiring coronary artery bypass surgery with cardiopulmonary bypass
* Wrriten consent obtained

Exclusion Criteria

* Non-primary cardiac surgery
* Preoperative liver or renal dysfunction
* Preoperative coagulation disorder
* Allergy
* Pregnancy or lactation
* Disabled in spirit or law
* Fatal conditions such as tumour

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No