Prospective Trial of Tranexamic Acid in Cardiac Surgery

January 29, 2016 updated by: Hongwen Ji

A Randomized Double-blinded Trial to Explore the Optimum Dose of Tranexamic Acid in Cardiopulmonary Bypass Cardiac Surgery

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

955

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100037
        • Cardiovascular Institute and Fuwai Hospital, CAMS&PUMC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: small dose
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
Drug: Tranexamic Acid
The loading doses were given in 15 minutes when incision.
Other Names:
  • SINE
  • Tranexamic Acid Injection
  • 120902
EXPERIMENTAL: medium dose
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
Drug: Tranexamic Acid
The loading doses were given in 15 minutes when incision.
Other Names:
  • SINE
  • Tranexamic Acid Injection
  • 120902
EXPERIMENTAL: large dose
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
Drug: Tranexamic Acid
The loading doses were given in 15 minutes when incision.
Other Names:
  • SINE
  • Tranexamic Acid Injection
  • 120902

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Postoperative Blood Loss
Time Frame: 24hrs postoperatively
24hrs postoperatively

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of Participants Needs Allogenic Transfusion
Time Frame: on the 7th day postoperatively
on the 7th day postoperatively

Other Outcome Measures

Outcome Measure
Time Frame
Rate of Reexploration for Bleeding
Time Frame: on the 7th day postoperatively
on the 7th day postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hongwen Ji

Investigators

  • Principal Investigator: Haisong Lu, Cardiovascular Institute and Fuwai Hospital, CAMS&PUMC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2012

Primary Completion (ACTUAL)

September 1, 2014

Study Completion (ACTUAL)

September 1, 2014

Study Registration Dates

First Submitted

November 12, 2013

First Submitted That Met QC Criteria

November 24, 2013

First Posted (ESTIMATE)

November 28, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

February 26, 2016

Last Update Submitted That Met QC Criteria

January 29, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2011GWH1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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