Dose Effect of Tranexamic Acid on the Incidence of Deep Venous Thrombus in Cardiac Surgery

February 9, 2019 updated by: SHI Jia

Dose Effect of Tranexamic Acid on the Incidence of Deep Venous Thrombus in Cardiac Surgery With Cardiopulmonary Bypass

In recent years, the lysine analogs tranexamic acid (TXA) has gained wide use in cardiac surgery as a blood-sparing agent. However, the safety of the drug and its impact on overall outcomes of cardiac surgery remains debated. The current study evaluates the dose effect of TXA on the incidence of deep venous thrombus (DVT) in cardiac surgery with cardiopulmonary bypass. Also, the dose effect of TXA on bleeding and allogeneic transfusion is evaluated.

Study Overview

Status

Unknown

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

360

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 Contact

Study Locations

      • Beijing, China, 100037
        • Chinese Academy of Medical Sciences, Fuwai Hospital

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:

  • Patients receiving selective cardiac surgery with cardiopulmonary bypass due to coronary, valvular or congenital heart disease
  • Written consent obtained

Exclusion Criteria:

  • Allergy or contraindication to tranexamic acid
  • Severe renal impairment (serum creatinine >250 μmol/l, or estimated creatinine clearance <25 ml/min)
  • Thromboembolic disease including but not limited to: history of pulmonary embolism, spontaneous arterial thrombosis or familial hypercoaguability (eg. Lupus anticoagulant, protein C deficiency)
  • Thrombocytopenia defined as a platelet count <100,000/ml
  • Coagulopathy defined as an international normalized ratio > 1.5 prior to surgery
  • Currently enrolled in another perioperative interventional study
  • Pregnancy or lactation

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 Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Dose group 1
The dose regimen of tranexamic acid in group 1 includes a loading dose of 30mg/kg before skin incision and a maintenance dose of 20mg/kg/hr until the end of the operation.
Tranexamic acid will be delivered by loading dose plus maintenance infusion until the end of the operation.
Experimental: Dose group 2
The dose regimen of tranexamic acid in group 2 includes a loading dose of 20mg/kg before skin incision and a maintenance dose of 15mg/kg/hr until the end of the operation.
Tranexamic acid will be delivered by loading dose plus maintenance infusion until the end of the operation.
Active Comparator: Dose group 3
The dose regimen of tranexamic acid in group 3 includes a loading dose of 10mg/kg before skin incision and a maintenance dose of 10mg/kg/hr until the end of the operation.
Tranexamic acid will be delivered by loading dose plus maintenance infusion until the end of the operation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The incidence of deep venous thrombosis
Time Frame: Within 7 days postoperatively
Defined as the incidence of new-onset deep venous thrombosis postoperatively diagnosed by ultrasound
Within 7 days postoperatively

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The rate of new-onset thrombotic events
Time Frame: Within 90 days postoperatively
Thrombotic events include ischemic stroke, renal failure, myocardial infarction and pulmonary embolism
Within 90 days postoperatively
The rate of allogeneic RBC transfusion
Time Frame: Within 30 days postoperatively
Allogeneic blood product includes packed red blood cell
Within 30 days postoperatively
The volume of allogeneic RBC transfusion
Time Frame: Within 30 days postoperatively
Allogeneic blood product includes packed red blood cell
Within 30 days postoperatively
Length of stay in ICU and hospital
Time Frame: Within 90 days postoperatively
The time interval between the end of the operation and the discharge from ICU or the hospital.
Within 90 days postoperatively

Collaborators and Investigators

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

Sponsor

Investigators

  • Principal Investigator: Jia Shi, M.D., Fuwai Hospital

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 (Anticipated)

March 1, 2019

Primary Completion (Anticipated)

February 28, 2020

Study Completion (Anticipated)

March 31, 2020

Study Registration Dates

First Submitted

February 1, 2019

First Submitted That Met QC Criteria

February 9, 2019

First Posted (Actual)

February 12, 2019

Study Record Updates

Last Update Posted (Actual)

February 12, 2019

Last Update Submitted That Met QC Criteria

February 9, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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