Clinical trial NCT05806346: Goal-directed vs. Empirical Tranexamic Acid Administrationin Cardiovascular Surgery
Official title: Tranexamic Acid Administration Strategies in Cardiovascular Surgery: Goal-directed Tranexamic Acid Administration Based on Viscoelastic Test vs. Empirical Tranexamic Acid Administration
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Heart Diseases
Vascular Diseases
Transfusion Related Complication
Coagulation Disorder, Blood
Fibrinolysis; Hemorrhage
Lead sponsor: Konkuk University Medical Center
Sponsor class: OTHER
Collaborators: name: Korea Health Industry Development Institute
name: Helptrial
name: Asan Medical Center
name: Samsung Medical Center
First posted: 2023-04-10
Enrollment: 764
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized prospective double-blind placebo-controlled multicenter non-inferior
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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

Primary outcomes:
measure: postoperative bleeding
timeFrame: 24 hours
Secondary outcomes:
measure: postoperative transfusion amount
timeFrame: 24 hours
measure: postoperative transfusion rate
timeFrame: 24 hours
measure: the lowest postoperative hemoglobin value
timeFrame: 24 hours
measure: incidence of reoperation
timeFrame: 1 week
measure: amount of intraoperative cell salvage
timeFrame: 1 hour
measure: viscoelastic whole blood profile
timeFrame: 1 hour
measure: incidence of seizure
timeFrame: 1 week
measure: incidence of thromboembolic complications
timeFrame: 1 week
measure: duration of mechanical ventilation
timeFrame: 1 week
measure: length of stays in the ICU and hospital
timeFrame: 1 week
measure: total cost
timeFrame: 2 week
measure: incidence of taking renal replacement therapy
timeFrame: 1 week
measure: incidence of acute kidney injury
timeFrame: 1 week
measure: incidence of postoperative delirium
timeFrame: 1 week
measure: incidence of applying for mechanical circulatory support
timeFrame: 1 week
measure: in-hospital mortality
timeFrame: 1 week
measure: central laboratory blood tests
timeFrame: 1 week
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Konkuk University Medical Center
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
Study officials:
affiliation: Konkuk University Medical Center
name: Tae-Yop Kim, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: