Blood Transfusion, Cardiac Surgical Procedures, Tranexamic Acid
Conditions
Keywords
Cardiac Surgery, Blood transfusion, Blood loss, Tranexamic Acid, Dose regimen
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.
Interventions
DRUGTranexamic acid
The drug used in this RCT is tranexamic acid. We used three different doses of TXA in three groups.
Sponsors
Chinese Academy of Medical Sciences, Fuwai Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| total postoperative drainage | from the operation day to the discharge，an average of 7 days | The total chest tube drainage postoperatively |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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） |
| 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 |
| rate of death | from the operation day to three months after surgery | rate of death |
Countries
China
Outcome results
None listed