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Dose-ranging Study of Tranexamic Acid in Valve Surgery

NCT ID: NCT01191554

Last Updated: 2012-11-06

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

COMPLETED

Clinical Phase

NA

Total Enrollment

175 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-09-30

Study Completion Date

2011-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Hemorrhage Valvular Heart Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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High dosage

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.

Group Type EXPERIMENTAL

Tranexamic Acid

Intervention Type DRUG

High and low dosage. Loading dose followed by continuous infusion in operation.

Low dosage

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.

Group Type EXPERIMENTAL

Tranexamic Acid

Intervention Type DRUG

High and low dosage. Loading dose followed by continuous infusion in operation.

Interventions

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Tranexamic Acid

High and low dosage. Loading dose followed by continuous infusion in operation.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chinese Academy of Medical Sciences, Fuwai Hospital

OTHER

Sponsor Role lead

Responsible Party

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Guyan Wang

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Lihuan Li, M.D

Role: STUDY_CHAIR

Fuwai Hospital & Cardiovascular Institute

Locations

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Cardiovascular Institute and Fuwai Hospital

Beijing, , China

Site Status

Countries

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China

Other Identifiers

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FW2009006

Identifier Type: -

Identifier Source: org_study_id