Goal-directed vs. Empirical Tranexamic Acid Administrationin Cardiovascular Surgery

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

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.

Study Overview

• Status: Recruiting
• Conditions: Heart Diseases; Vascular Diseases; Fibrinolysis; Hemorrhage; Transfusion Related Complication; Coagulation Disorder, Blood
• Intervention / Treatment: Drug: TXA administration; Drug: Placebo administration

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 Type: Interventional
• Enrollment (Estimated): 764
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Soi Lee; Phone Number: +82 10 4418 9288; Email: soileekku@gmail.com

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Recruiting
    • Asan Medical Center
    • Contact: Jaesik Nam; Email: jaesik_nam@naver.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Empirical 1: TXA and 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	Drug: TXA administration; Tranexamic acid intravenous administration; Other Names: Tranexamic acid; Drug: Placebo administration; Placebo (normal saline) intravenous administration; Other Names: Placebo (normal saline)
Active Comparator: Empirical 2: 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	Drug: TXA administration; Tranexamic acid intravenous administration; Other Names: Tranexamic acid
Experimental: Goal-directed 1: 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	Drug: TXA administration; Tranexamic acid intravenous administration; Other Names: Tranexamic acid; Drug: Placebo administration; Placebo (normal saline) intravenous administration; Other Names: Placebo (normal saline)
Experimental: Goal-directed 2: TXA and 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	Drug: Placebo administration; Placebo (normal saline) intravenous administration; Other Names: Placebo (normal saline)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
postoperative bleeding	bleeding amount though chest drainage tubes during the 1st postoperative 24 hour	24 hours

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Konkuk University Medical Center
• Collaborators: Samsung Medical Center; Asan Medical Center; Korea Health Industry Development Institute; Helptrial
• Investigators: Principal Investigator: Tae-Yop Kim, MD, PhD, Konkuk University Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2023
• Primary Completion (Estimated): August 31, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: March 28, 2023
• First Submitted That Met QC Criteria: March 28, 2023
• First Posted (Actual): April 10, 2023

Study Record Updates

• Last Update Posted (Estimated): January 3, 2024
• Last Update Submitted That Met QC Criteria: December 29, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Hematologic Diseases; Hemorrhagic Disorders; Heart Diseases; Hemostatic Disorders; Blood Coagulation Disorders; Vascular Diseases; Hemorrhage; Molecular Mechanisms of Pharmacological Action; Fibrin Modulating Agents; Antifibrinolytic Agents; Hemostatics; Coagulants; Tranexamic Acid
• Other Study ID Numbers: HI22C1952-1-3

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No