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NCT Number: NCT04911413

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

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.

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Key information

Conditions

Cardiac Surgical Procedures Blood Transfusion Hemorrhage Pathologic Processes Pathological Conditions, Signs and Symptoms Tranexamic Acid

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Fuwai Hospital, National Center for Cardiovascular Diseases

Beijing, Beijing Municipality, 100037, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Tranexamic Acid

Drug

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

Other names: Cyklokapron, Transamin

Primary outcomes

  1. total postoperative drainage

    Time frame: from the operation day to the discharge，an average of 7 days

    The total chest tube drainage postoperatively

Secondary outcomes

  1. Red blood cells transfusion rate（%），Red blood cells transfusion volume（ml）

    Time frame: 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）

  2. Fresh frozen plasma transfusion rate（%），Fresh frozen plasma transfusion volume（ml）

    Time frame: 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）

  3. Platelet transfusion rate（%），Platelet transfusion volume（ml）

    Time frame: 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）

  4. repeat surgery because of bleeding

    Time frame: from the operation day to the discharge，an average of 7 days

    rate of repeat surgery due to massive bleeding

  5. rate of death

    Time frame: from the operation day to three months after surgery

    rate of death

  6. seizure attack

    Time frame: from the operation day to three months after surgery

    any seizure attack is recorded

  7. length of stay in ICU and hospital

    Time frame: from the operation day to the discharge，an average of 7 days

    the length of stay in ICU and hospital

Sponsors and collaborators

Lead sponsor

Chinese Academy of Medical Sciences, Fuwai Hospital

Other

Registry information

Important dates

Study start
2017
Primary completion
2021
Study completion
2021
First posted
Jun 3, 2021
Registry last updated
Aug 31, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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