Goal-directed vs. Empirical Tranexamic Acid Administrationin Cardiovascular Surgery

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

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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