Tranxemic Acid and Vitamin K Injection to Control Upper Gastrointestinal Bleeding in Cirrhotic Patients

Last updated: March 11, 2025
Sponsor: Tanta University
Overall Status: Active - Recruiting

Phase

4

Condition

Scar Tissue

Liver Disorders

Hemorrhage

Treatment

Tranexamic Acid and vitamin K

Placebo

Clinical Study ID

NCT06881628
36264PR982/12/24
  • Ages > 18
  • All Genders

Study Summary

The goal of this randomized controlled clinical trial is to evaluate the efficacy of Tranexamic acid and vitamin K injection versus placebo in control of upper gastrointestinal bleeding (UGIB) in Egyptian cirrhotic patients.

Researchers will compare the bleeding and mortality rates (at 5 days and 6 weeks post endoscopic intervention for UGIB) between patients receiving tranxemic acid and vitamin K injection and patients receiving placebo.

Participants presenting with variceal bleeding will be randomly assigned to receive tranexamic acid (1 g loading dose followed by 3 g maintenance dose over 24- 48 hours) and intravenous injection of 10 mg daily of vitamin K for 24-48 h or matching placebo group receiving IV saline. Intervention will be carried out besides the recommended initial management of airway management, hemodynamic stabilization, octreotide analogue, PPI, antibiotics, and endoscopy.

Follow-up All patients will be kept at the hospital for at least 5 days from the index bleed and will be discharged if no other reason was observed to keep them at the hospital.

The rate of rebleeding, need for blood transfusion, hospital stay, adverse effects, and mortality rate were evaluated and compared across the groups.

At discharge, all patients will be started on nonselective beta-blockers if there was no contraindication. They will be given instructions to attend to hospital if they noticed any melena or hematemesis.

Second follow-up after 6 weeks for the rebleeding rate and mortality related to bleeding rate.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Age ≥18 years

  • Liver cirrhosis

  • Upper gastrointestinal bleeding

Exclusion

Exclusion Criteria:

  • Patients aged < 18 years

  • Allergy to tranexamic acid

  • Allergy to vitamin K injection

  • DIC.

  • Thromboembolic event.

  • Pregnancy or lactation.

  • End-stage renal disease.

  • Unwilling to participate in our study.

Study Design

Total Participants: 194
Treatment Group(s): 2
Primary Treatment: Tranexamic Acid and vitamin K
Phase: 4
Study Start date:
December 02, 2024
Estimated Completion Date:
December 30, 2025

Connect with a study center

  • Tanta University Hospitals

    Tanta, Gharbyea 31516
    Egypt

    Active - Recruiting

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.