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

Sponsor

Chinese Academy of Medical Sciences, Fuwai Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT04911413

Collaborator

(none)

210

Enrollment

Location

Arms

45.4

Actual Duration (Months)

4.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Cardiac Surgical Procedures Blood Transfusion Tranexamic Acid	Drug: Tranexamic acid	Phase 4

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 Design

Study Type:

Interventional

Actual Enrollment :

210 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Sep 1, 2017

Actual Primary Completion Date :

Mar 5, 2021

Actual Study Completion Date :

Jun 15, 2021

Arms and Interventions

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: Cyklokapron Transamin
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: Cyklokapron Transamin
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: Cyklokapron Transamin

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:

Cyklokapron

Transamin

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:

Cyklokapron

Transamin

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:

Cyklokapron

Transamin

Outcome Measures

Primary Outcome Measures

total postoperative drainage [from the operation day to the discharge，an average of 7 days]
The total chest tube drainage postoperatively

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.