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NCT Number: NCT05806346

Goal-directed vs. Empirical Tranexamic Acid Administrationin Cardiovascular Surgery

The present study is a multi-center randomized prospective placebo-controlled non-inferiority trial.

The study's primary objective is to compare the amounts of postoperative bleeding using two different TXA administration strategies: empirical TXA administration vs. viscoelastic test-based goal-directed TXA administration in cardiovascular surgery.

The secondary objectives include comparing the incidents of hyper-fibrinolysis, thromboembolic complications, and postoperative seizures.

Researchers assumed that goal-directed tranexamic acid (TXA) administration using viscoelastic field tests would not be inferior to the empirical TXA administration strategy in reducing postoperative bleeding and hyper-fibrinolysis. It also would be beneficial in lowering TXA-induced thromboembolic complications and seizures.

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Key information

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Asan Medical Center, Seoul, South Korea

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About this study

The present study is a multi-center randomized prospective placebo-controlled non-inferiority trial.

This study's primary objective is to compare the amounts of postoperative bleeding during postoperative 24 hours through chest tube drainage using two different tranexamic acid (TXA) administration strategies: empirical TXA administration vs. viscoelastic test-based goal-directed TXA administration in cardiovascular surgery.

The secondary objectives include determining the inter-group differences in hyper-fibrinolysis, thromboembolic complications, and postoperative seizures.

Researchers hypothesized that goal-directed TXA administration using viscoelastic field tests would not be inferior to the empirical TXA administration strategy in reducing postoperative bleeding and hyper-fibrinolysis. Researchers also expect that goal-directed TXA administration would be beneficial in lowering TXA-induced thromboembolic complications and seizure risks.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • patients who will undergo elective cardiovascular surgery employing cardiopulmonary bypass
  • patients who provide written informed consent

Exclusion criteria

  • pregnancy
  • refusal of allogenic blood transfusion
  • taking thrombin
  • history of thromboembolic and familial hypercoagulability disease
  • recent history of myocardial infarction or ischemic cerebral infarction (within 90 days)
  • hypersensitive to TXA
  • histroy of convulsion or epilepsy
  • taking hemodialysis
  • history of Heparin-induced thrombocytopenia

Treatment and study plan

TXA administration

Drug

Tranexamic acid intravenous administration

Other names: Tranexamic acid

Placebo Administration

Drug

Placebo (normal saline) intravenous administration

Other names: Placebo (normal saline)

Primary outcomes

  1. postoperative bleeding

    Time frame: 24 hours

    bleeding amount though chest drainage tubes during the 1st postoperative 24 hour

Secondary outcomes

  1. postoperative transfusion amount

    Time frame: 24 hours

    amounts of transfused red blood cells, plasma, platelet and cryoprecipitate

  2. postoperative transfusion rate

    Time frame: 24 hours

    incidents of red blood cells, plasma, platelet and cryoprecipitate transfusions

  3. the lowest postoperative hemoglobin value

    Time frame: 24 hours

    the nadir hemoglobin value during one postoperative days

  4. incidence of reoperation

    Time frame: 1 week

    incidence of reoperation due to postoperative bleeding

  5. amount of intraoperative cell salvage

    Time frame: 1 hour

    amounts of infused salvaged blood

  6. viscoelastic whole blood profile

    Time frame: 1 hour

    values of intraoperative CT-EXTEM, CFT-EXTEM, A10-EXTEM, MCF-EXTEM, ML-EXTEM, CT-FIBTEM, CFT-FIBTEM, A10-FIBTEM, MCF-FIBTEM, ML-FIBTEM in rotational thromboelastometry

  7. incidence of seizure

    Time frame: 1 week

    incidence of postoperative seizure till the hospital discharge

  8. incidence of thromboembolic complications

    Time frame: 1 week

    incidence of postoperative myocardia infarction, stroke, pulmonary embolism, gut infarction till the hospital discharge

  9. duration of mechanical ventilation

    Time frame: 1 week

    duration of postoperative ventilatory care

  10. length of stays in the ICU and hospital

    Time frame: 1 week

    duration of stay in the ICU and hospital

  11. total cost

    Time frame: 2 week

    total expense paid at the discharge

  12. incidence of taking renal replacement therapy

    Time frame: 1 week

    incidence of taking hemodylaysis

  13. incidence of acute kidney injury

    Time frame: 1 week

    diagnosed by KIDGO criteria

  14. incidence of postoperative delirium

    Time frame: 1 week

    delirium digested by CAM-ICU

  15. incidence of applying for mechanical circulatory support

    Time frame: 1 week

    incidences of applying IABP, ECMO, VAD

  16. in-hospital mortality

    Time frame: 1 week

    hospital death

  17. central laboratory blood tests

    Time frame: 1 week

    hemoglobin, platelet number, Prothrombin timeI activated partial thromboplastin timePTT , fibrinogen concentration, d-dimer

Study contacts

Contact information is provided by the study sponsor or research team.

Tae-Yop Kim, MD PhD

CONTACT

[email protected]

+82-10-8811-6942

Sponsors and collaborators

Lead sponsor

Konkuk University Medical Center

Other

Collaborators

  • Asan Medical Center
  • Helptrial
  • Korea Health Industry Development Institute
  • Samsung Medical Center

Registry information

Official study title

Tranexamic Acid Administration Strategies in Cardiovascular Surgery: Goal-directed Tranexamic Acid Administration Based on Viscoelastic Test vs. Empirical Tranexamic Acid Administration

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Apr 10, 2023
Registry last updated
Dec 18, 2024

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

View the official ClinicalTrials.gov record (opens in a new tab)

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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