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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Cardiac Surgical Procedures, Blood Transfusion, Tranexamic Acid

Intervention / Treatment
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* Drug: Tranexamic acid


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: low-dose group,<br>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<br>* The drug used in this RCT is tranexamic acid. We used three different doses of TXA in three groups.<br>* Other names: Transamin;|
| Experimental: middle-dose group,<br>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<br>* The drug used in this RCT is tranexamic acid. We used three different doses of TXA in three groups.<br>* Other names: Transamin;|
| Experimental: high-dose group<br>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<br>* The drug used in this RCT is tranexamic acid. We used three different doses of TXA in three groups.<br>* Other names: Transamin;|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Blood loss, Cardiac Surgery, Blood transfusion, Tranexamic Acid, Dose regimen