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

Blood Transfusion Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04911413
• Other study ID #: TXA dosage trial 2
• Status: Completed
• Phase: Phase 4
• Start date: September 1, 2017
• Est. completion date: June 15, 2021

Study information

• Verified date: August 2021
• Source: Chinese Academy of Medical Sciences, Fuwai Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 210
• Est. completion date: June 15, 2021
• Est. primary completion date: March 5, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Blood Transfusion
• Cardiac Surgical Procedures
• Tranexamic Acid

Intervention

Drug:
• Tranexamic acid
The drug used in this RCT is tranexamic acid. We used three different doses of TXA in three groups.

Locations

Country	Name	City	State
China	Fuwai Hospital, National Center for Cardiovascular Diseases	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Chinese Academy of Medical Sciences, Fuwai Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	total postoperative drainage	The total chest tube drainage postoperatively	from the operation day to the discharge,an average of 7 days
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	rate of death	rate of death	from the operation day to three months after surgery
Secondary	seizure attack	any seizure attack is recorded	from the operation day to three months after surgery
Secondary	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