Goal-directed vs. Empirical Tranexamic Acid Administrationin Cardiovascular Surgery

Not Applicable

Recruiting

• Conditions: Heart Diseases; Fibrinolysis; Hemorrhage; Coagulation Disorder, Blood; Vascular Diseases; Transfusion Related Complication
• Interventions: Drug: TXA administration; Drug: Placebo administration

• Registration Number: NCT05806346
• Lead Sponsor: Konkuk University Medical Center

Brief Summary

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2023-03-28
• Study First Submitted QC: 2023-03-28
• Study First Posted: 2023-04-10
• Study Start: 2023-08-01
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-15
• Last Update Posted: 2024-12-18
• Primary Completion: 2025-04-30
• Study Completion: 2025-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 764

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Empirical 1: TXA and Placebo administration	TXA administration	Tranexamic acid administration, regardless of the result of rotational thromboelastometry. Placebo administration, at LI60 \< 85 % or A10\< 40 mm in EXTEM of rotational thromboelastometry
Empirical 1: TXA and Placebo administration	Placebo administration	Tranexamic acid administration, regardless of the result of rotational thromboelastometry. Placebo administration, at LI60 \< 85 % or A10\< 40 mm in EXTEM of rotational thromboelastometry
Goal-directed 1: Placebo administration	TXA administration	Placebo administration, regardless of the result of rotational thromboelastometry. Tranexamic acid administration at LI60 \< 85 % or A10 \< 40 mm in EXTEM of rotational thromboelastometry
Empirical 2: TXA administration	TXA administration	Tranexamic acid administration, regardless of the result of rotational thromboelastometry. Placebo discard, at LI60 ≥ 85% or A10 ≥ 40 mm in EXTEM of rotational thromboelastometry
Goal-directed 1: Placebo administration	Placebo administration	Placebo administration, regardless of the result of rotational thromboelastometry. Tranexamic acid administration at LI60 \< 85 % or A10 \< 40 mm in EXTEM of rotational thromboelastometry
Goal-directed 2: TXA and Placebo administration	Placebo administration	Placebo administration, regardless of the result of rotational thromboelastometry. Tranexamic acid discard at LI60 ≥ 85% or A10 ≥ 40 mm in EXTEM of rotational thromboelastometry

Primary Outcome Measures

Name	Time	Method
postoperative bleeding	24 hours	bleeding amount though chest drainage tubes during the 1st postoperative 24 hour

Secondary Outcome Measures

Name	Time	Method
postoperative transfusion amount	24 hours	amounts of transfused red blood cells, plasma, platelet and cryoprecipitate
postoperative transfusion rate	24 hours	incidents of red blood cells, plasma, platelet and cryoprecipitate transfusions
the lowest postoperative hemoglobin value	24 hours	the nadir hemoglobin value during one postoperative days
incidence of reoperation	1 week	incidence of reoperation due to postoperative bleeding
amount of intraoperative cell salvage	1 hour	amounts of infused salvaged blood
viscoelastic whole blood profile	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
incidence of seizure	1 week	incidence of postoperative seizure till the hospital discharge
incidence of thromboembolic complications	1 week	incidence of postoperative myocardia infarction, stroke, pulmonary embolism, gut infarction till the hospital discharge
duration of mechanical ventilation	1 week	duration of postoperative ventilatory care
length of stays in the ICU and hospital	1 week	duration of stay in the ICU and hospital
total cost	2 week	total expense paid at the discharge
incidence of taking renal replacement therapy	1 week	incidence of taking hemodylaysis
incidence of acute kidney injury	1 week	diagnosed by KIDGO criteria
incidence of postoperative delirium	1 week	delirium digested by CAM-ICU
incidence of applying for mechanical circulatory support	1 week	incidences of applying IABP, ECMO, VAD
in-hospital mortality	1 week	hospital death
central laboratory blood tests	1 week	hemoglobin, platelet number, Prothrombin timeI activated partial thromboplastin timePTT , fibrinogen concentration, d-dimer

Trial Locations

Locations (3)

Konkuk University Medical Center; 🇰🇷 Seoul, Korea, Republic of

Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of

Asan Medical Center; 🇰🇷 Seoul, Korea, Republic of