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Dose-ranging Study of Tranexamic Acid in Valve Surgery

Primary Purpose

Hemorrhage, Valvular Heart Surgery

Status

Completed

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

Tranexamic Acid

About this trial

This is an interventional treatment trial for Hemorrhage

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Cardiovascular Institute and Fuwai Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

High dosage

Low dosage

Arm 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.

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.

Outcomes

Primary Outcome Measures

Frequency of allogeneic red blood cells transfused

Secondary Outcome Measures

Chest tube drainage

Full Information

NCT ID

NCT01191554

First Posted

August 30, 2010

Last Updated

November 2, 2012

Sponsor

Chinese Academy of Medical Sciences, Fuwai Hospital

1. Study Identification

Unique Protocol Identification Number

NCT01191554

Brief Title

Dose-ranging Study of Tranexamic Acid in Valve Surgery

Official Title

Comparison of Two Tranexamic Acid Dose Regimens on Postoperative Bleeding and Transfusion Needs in Primary Valve Surgery

Study Type

Interventional

2. Study Status

Record Verification Date

November 2012

Overall Recruitment Status

Completed

Study Start Date

September 2010 (undefined)

Primary Completion Date

September 2011 (Actual)

Study Completion Date

October 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Chinese Academy of Medical Sciences, Fuwai Hospital

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hemorrhage, Valvular Heart Surgery

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

175 (Actual)

8. Arms, Groups, and Interventions

Arm Title

High dosage

Arm Type

Experimental

Arm 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.

Arm Title

Low dosage

Arm Type

Experimental

Arm 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.

Intervention Type

Drug

Intervention Name(s)

Tranexamic Acid

Intervention Description

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

Primary Outcome Measure Information:

Title

Frequency of allogeneic red blood cells transfused

Time Frame

7 days post-operation

Secondary Outcome Measure Information:

Title

Chest tube drainage

Time Frame

6 hours post-operation

Title

Chest tube drainage

Time Frame

24 hours post-operation

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Lihuan Li, M.D

Organizational Affiliation

Fuwai Hospital & Cardiovascular Institute

Official's Role

Study Chair

Facility Information:

Facility Name

Cardiovascular Institute and Fuwai Hospital

City

Beijing

ZIP/Postal Code

100037

Country

China

12. IPD Sharing Statement

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Dose-ranging Study of Tranexamic Acid in Valve Surgery

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