Goal-directed vs. Empirical Tranexamic Acid Administrationin Cardiovascular Surgery

Heart Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05806346
• Other study ID #: HI22C1952-1-3
• Status: Recruiting
• Phase: N/A
• Start date: August 1, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: December 2023
• Source: Konkuk University Medical Center
• Contact: Soi Lee
• Phone: +82 10 4418 9288
• Email: soileekku[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 764
• Est. completion date: December 31, 2024
• Est. primary completion date: August 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Drug:
• TXA administration
Tranexamic acid intravenous administration
• Placebo administration
Placebo (normal saline) intravenous administration

Locations

Country	Name	City	State
Korea, Republic of	Asan Medical Center	Seoul

Sponsors (5)

Lead Sponsor	Collaborator
Konkuk University Medical Center	Asan Medical Center, Helptrial, Korea Health Industry Development Institute, Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

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