Comparison of Three Tranexamic Acid Dose Regimens in Patients Undergoing Cardiac Valve Surgery
- Conditions
- Blood TransfusionTranexamic AcidCardiac Surgical Procedures
- Interventions
- Registration Number
- NCT04911413
- Lead Sponsor
- Chinese Academy of Medical Sciences, Fuwai Hospital
- 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 210
- patients aged between 18 to 60 years old scheduled for cardiac valve surgery (replacement or plasty) requiring CPB
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description low-dose group, Tranexamic acid 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 high-dose group Tranexamic acid 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 middle-dose group, Tranexamic acid 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
- Primary Outcome Measures
Name Time Method total postoperative drainage from the operation day to the discharge，an average of 7 days The total chest tube drainage postoperatively
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
Fuwai Hospital, National Center for Cardiovascular Diseases
🇨🇳Beijing, Beijing, China