Clinical trial NCT04911413: Comparison of Three Tranexamic Acid Dose Regimens in Patients Undergoing Cardiac Valve Surgery
Official title: Comparison of Three Tranexamic Acid Dose Regimens in Patients Undergoing Cardiac Valve Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Cardiac Surgical Procedures
Blood Transfusion
Tranexamic Acid
Keywords: Cardiac Surgery
Blood transfusion
Blood loss
Tranexamic Acid
Dose regimen
Lead sponsor: Chinese Academy of Medical Sciences, Fuwai Hospital
Sponsor class: OTHER
First posted: 2021-06-03
Enrollment: 210
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: total postoperative drainage
timeFrame: from the operation day to the discharge，an average of 7 days
Secondary outcomes:
measure: Red blood cells transfusion rate（%），Red blood cells transfusion volume（ml）
timeFrame: from the operation day to the discharge，an average of 7 days
measure: Fresh frozen plasma transfusion rate（%），Fresh frozen plasma transfusion volume（ml）
timeFrame: from the operation day to the discharge，an average of 7 days
measure: Platelet transfusion rate（%），Platelet transfusion volume（ml）
timeFrame: from the operation day to the discharge，an average of 7 days
measure: repeat surgery because of bleeding
timeFrame: from the operation day to the discharge，an average of 7 days
measure: rate of death
timeFrame: from the operation day to three months after surgery
measure: seizure attack
timeFrame: from the operation day to three months after surgery
measure: length of stay in ICU and hospital
timeFrame: from the operation day to the discharge，an average of 7 days
Other outcomes:
Locations:
city: Beijing
country: China
facility: Fuwai Hospital, National Center for Cardiovascular Diseases
state: Beijing
Study officials:
References: