Goal-directed vs. Empirical Tranexamic Acid Administrationin Cardiovascular Surgery

NCT05806346 | Recruiting DMC

• 1 other identifier: HI22C1952-1-3
• Study Type: interventional
• Target: 764
• Locations: 1 country
• Sites: 3

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• postoperative bleeding

  bleeding amount though chest drainage tubes during the 1st postoperative 24 hour

  24 hours

Secondary Outcomes (17)

• postoperative transfusion amount

  24 hours

• postoperative transfusion rate

  24 hours

• the lowest postoperative hemoglobin value

  24 hours

• incidence of reoperation

  1 week

• amount of intraoperative cell salvage

  1 hour

Study Arms (4)

Empirical 1: TXA and Placebo administration

ACTIVE COMPARATOR

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; Drug: Placebo administration

Empirical 2: TXA administration

ACTIVE COMPARATOR

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

Goal-directed 1: Placebo administration

EXPERIMENTAL

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; Drug: Placebo administration

Goal-directed 2: TXA and Placebo administration

EXPERIMENTAL

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

Interventions

TXA administration DRUG

Tranexamic acid intravenous administration

Also known as: Tranexamic acid

Empirical 1: TXA and Placebo administration; Empirical 2: TXA administration; Goal-directed 1: Placebo administration

Placebo administration DRUG

Placebo (normal saline) intravenous administration

Also known as: Placebo (normal saline)

Empirical 1: TXA and Placebo administration; Goal-directed 1: Placebo administration; Goal-directed 2: TXA and Placebo administration

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients who will undergo elective cardiovascular surgery employing cardiopulmonary bypass
• patients who provide written informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Konkuk University Medical Center: lead
• Korea Health Industry Development Institute: collaborator
• Helptrial: collaborator
• Asan Medical Center: collaborator
• Samsung Medical Center: collaborator

Study Sites (3)

Konkuk University Medical Center

Seoul, 05030, South Korea

RECRUITING

Samsung Medical Center

Seoul, 06351, South Korea

RECRUITING

Asan Medical Center

Seoul, South Korea

RECRUITING

Related Publications (1)

• Nam JS, Oh CS, Kim JY, Choi DK, Oh AR, Park J, Lee JH, Yun SC, Kim KW, Jang MU, Kim TY, Choi IC. A multi-center, double-blind, placebo-controlled, randomized, parallel-group, non-inferiority study to compare the efficacy of goal-directed tranexamic acid administration based on viscoelastic test versus preemptive tranexamic acid administration on postoperative bleeding in cardiovascular surgery (GDT trial). Trials. 2024 Sep 27;25(1):623. doi: 10.1186/s13063-024-08467-1.

  PMID: 39334224 DERIVED

MeSH Terms

Conditions

Heart Diseases; Vascular Diseases; Blood Coagulation Disorders; Hemorrhage

Interventions

Tranexamic Acid; Saline Solution

Condition Hierarchy (Ancestors)

Cardiovascular Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Tae-Yop Kim, MD, PhD

  Konkuk University Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tae-Yop Kim, MD PhD

CONTACT

+82-10-8811-6942; taeyop@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: placebo-controlled
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Anesthesiology

Model Details: randomized prospective double-blind placebo-controlled multicenter non-inferior

Study Record Dates

• First Submitted: March 28, 2023
• First Posted: April 10, 2023
• Study Start: August 1, 2023
• Primary Completion: April 30, 2025
• Study Completion: June 30, 2025
• Last Updated: December 18, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

KR (3)