Goal-directed vs. Empirical Tranexamic Acid Administrationin Cardiovascular Surgery

K

Konkuk University Medical Center

Status

Enrolling

Conditions

Transfusion Related Complication
Fibrinolysis; Hemorrhage
Vascular Diseases
Heart Diseases
Coagulation Disorder, Blood

Treatments

Drug: TXA administration
Drug: Placebo administration

Study type

Interventional

Funder types

Other

Identifiers

NCT05806346
HI22C1952-1-3

Details and patient eligibility

About

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.

Full description

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.

Enrollment

764 estimated patients

Sex

All

Ages

19+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Diagnostic

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

764 participants in 4 patient groups

Empirical 1: TXA and Placebo administration
Active Comparator group
Description:
Tranexamic acid administration, regardless of the result of rotational thromboelastometry. Placebo administration, at LI60 < 85 % or A10< 40 mm in EXTEM of rotational thromboelastometry
Treatment:
Drug: Placebo administration
Drug: TXA administration
Empirical 2: TXA administration
Active Comparator group
Description:
Tranexamic acid administration, regardless of the result of rotational thromboelastometry. Placebo discard, at LI60 ≥ 85% or A10 ≥ 40 mm in EXTEM of rotational thromboelastometry
Treatment:
Drug: TXA administration
Goal-directed 1: Placebo administration
Experimental group
Description:
Placebo administration, regardless of the result of rotational thromboelastometry. Tranexamic acid administration at LI60 < 85 % or A10 < 40 mm in EXTEM of rotational thromboelastometry
Treatment:
Drug: Placebo administration
Drug: TXA administration
Goal-directed 2: TXA and Placebo administration
Experimental group
Description:
Placebo administration, regardless of the result of rotational thromboelastometry. Tranexamic acid discard at LI60 ≥ 85% or A10 ≥ 40 mm in EXTEM of rotational thromboelastometry
Treatment:
Drug: Placebo administration

Trial contacts and locations

0

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Central trial contact

Soi Lee

Data sourced from clinicaltrials.gov

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