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Goal-directed vs Preemptive Tranexamic Acid Administration in Non-cardiac Surgery

NCT05957822 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 148

Last updated 2024-05-14

No results posted yet for this study

Summary

The present study is a multi-center randomized prospective non-inferiority trial. The study's primary objective is to compare the coagulation profile upon using two different TXA administration strategies: empirical TXA administration vs. viscoelastic test-based goal-directed TXA administration in high-risk non-cardiac surgery. The secondary objectives include comparing the amount of bleeding, 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

  • Arthritis Knee
  • Spine Fusion
  • Prostate Cancer
  • Arthritis of Hip
  • Hepatic Cancer

Interventions

DRUG

TXA

Tranexamic acid injection 8-10mg/kg

DIAGNOSTIC_TEST

TEG6

performing thromboelastography (TEG6)

Sponsors & Collaborators

  • Korea Health Industry Development Institute

    collaborator OTHER_GOV

  • Asan Medical Center

    collaborator OTHER

  • Soon Chun Hyang University

    collaborator OTHER

  • Konkuk University Medical Center

    lead OTHER

Principal Investigators

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

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-02-10
Primary Completion
2024-12-01
Completion
2025-01-01

Countries

  • South Korea

Study Locations

More Related Trials

Entities

Diseases

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 NCT05957822 on ClinicalTrials.gov