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Goal-directed vs. Empirical Tranexamic Acid Administrationin Cardiovascular Surgery

NCT05806346 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 764

Last updated 2024-12-18

No results posted yet for this study

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

Interventions

DRUG

TXA administration

Tranexamic acid intravenous administration

DRUG

Placebo administration

Placebo (normal saline) intravenous administration

Sponsors & Collaborators

  • Korea Health Industry Development Institute

    collaborator OTHER_GOV

  • Helptrial

    collaborator UNKNOWN

  • Asan Medical Center

    collaborator OTHER

  • Samsung Medical Center

    collaborator OTHER

  • Konkuk University Medical Center

    lead OTHER

Principal Investigators

  • Tae-Yop Kim, MD, PhD · Konkuk University Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-08-01
Primary Completion
2025-04-30
Completion
2025-06-30

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05806346 on ClinicalTrials.gov