Comparison of Three Tranexamic Acid Dose Regimens in Patients Undergoing Cardiac Valve Surgery

This study compares the effect of three different dose levels of tranexamic acid（TXA）in reducing blood loss and transfusion requirements in cardiac valve surgery.

Study Overview

• Status: Completed
• Conditions: Blood Transfusion; Cardiac Surgical Procedures; Tranexamic Acid
• Intervention / Treatment: Drug: Tranexamic acid

Detailed Description

The effect of TXA to reduce perioperative blood loss and blood transfusion has been well established in many trials, but the optimal dosage of TXA in cardiac surgery has always been a problem of debate. This is a single-center randomized controlled trial to study different dose regimens of TXA in cardiac surgery. We use three different dose levels of TXA in cardiac valve surgery with CPB, and see if there are any differences in perioperative blood loss and transfusion requirements. Serious adverse events and seizure attacks are also recorded until three months after surgery.

• Study Type: Interventional
• Enrollment (Actual): 210
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100037
      • Fuwai Hospital, National Center for Cardiovascular Diseases

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• patients aged between 18 to 60 years old scheduled for cardiac valve surgery (replacement or plasty) requiring CPB

Exclusion Criteria:

• known allergy to TXA, combined CABG operation or other cardiac procedures other than valve surgery, previous cardiac surgery, EF<45% or cardiothoracic ratio>0.65, serious coagulation disorder, serious hepatic insufficiency, receiving antiplatelet therapy at any time within 7 days of surgery, receiving low molecular weight heparin at any time within 24 hours of surgery, and pregnancy.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: low-dose group,; A bolus of 10 mg/kg Tranexamic Acid followed by a maintenance dose of 10 mg/kg/h Tranexamic Acid until the end of surgery	Drug: Tranexamic acid; The drug used in this RCT is tranexamic acid. We used three different doses of TXA in three groups.; Other Names: Transamin; Cyklokapron
Experimental: middle-dose group,; A bolus of 20 mg/kg Tranexamic Acid followed by a maintenance dose of 15 mg/kg/h Tranexamic Acid until the end of surgery	Drug: Tranexamic acid; The drug used in this RCT is tranexamic acid. We used three different doses of TXA in three groups.; Other Names: Transamin; Cyklokapron
Experimental: high-dose group; A bolus of 30 mg/kg Tranexamic Acid followed by a maintenance dose of 20 mg/kg/h Tranexamic Acid until the end of surgery	Drug: Tranexamic acid; The drug used in this RCT is tranexamic acid. We used three different doses of TXA in three groups.; Other Names: Transamin; Cyklokapron

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
total postoperative drainage	The total chest tube drainage postoperatively	from the operation day to the discharge，an average of 7 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Red blood cells transfusion rate（%），Red blood cells transfusion volume（ml）	intraoperative and postoperative RBC transfusion rate and transfusion volume（for all patients and for transfused patients）	from the operation day to the discharge，an average of 7 days
Fresh frozen plasma transfusion rate（%），Fresh frozen plasma transfusion volume（ml）	intraoperative and postoperative FFP transfusion rate and transfusion volume（for all patients and for transfused patients）	from the operation day to the discharge，an average of 7 days
Platelet transfusion rate（%），Platelet transfusion volume（ml）	intraoperative and postoperative platelet transfusion rate and transfusion volume（for all patients and for transfused patients）	from the operation day to the discharge，an average of 7 days
repeat surgery because of bleeding	rate of repeat surgery due to massive bleeding	from the operation day to the discharge，an average of 7 days
rate of death	rate of death	from the operation day to three months after surgery
seizure attack	any seizure attack is recorded	from the operation day to three months after surgery
length of stay in ICU and hospital	the length of stay in ICU and hospital	from the operation day to the discharge，an average of 7 days

Collaborators and Investigators

• Sponsor: Chinese Academy of Medical Sciences, Fuwai Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2017
• Primary Completion (Actual): March 5, 2021
• Study Completion (Actual): June 15, 2021

Study Registration Dates

• First Submitted: May 25, 2021
• First Submitted That Met QC Criteria: May 27, 2021
• First Posted (Actual): June 3, 2021

Study Record Updates

• Last Update Posted (Actual): August 31, 2021
• Last Update Submitted That Met QC Criteria: August 26, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: Cardiac Surgery; Tranexamic Acid; Blood loss; Blood transfusion; Dose regimen
• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Fibrin Modulating Agents; Antifibrinolytic Agents; Hemostatics; Coagulants; Tranexamic Acid
• Other Study ID Numbers: TXA dosage trial 2

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