Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06881628

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Tanta University Hospitals

Tanta, Gharbyea, 31516, Egypt

Location status: Recruiting

Location contact

Dina H Ziada, MD

CONTACT

[email protected]

00201117109990

Mennat-Allah M El Sawaf, MD

SUB_INVESTIGATOR

Nabila A Elgazzar, MD

SUB_INVESTIGATOR

Rania M Elkafoury, MD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥18 years
  • Liver cirrhosis
  • Upper gastrointestinal bleeding

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.

Treatment and study plan

Tranexamic Acid and vitamin K

Drug

Tranxemic acid (1 g loading dose followed by 3 g maintenance dose over 24- 48 hours) and intravenous injection (10 mg daily of vitamin K for 24-48 h) along with initial management of airway management, hemodynamic stabilization, octreotide analogue, PPI, antibiotics, and endoscopy to control UGIB in cirrhotic patients.

Patients will be followed up after 5 days and 6 weeks to assess the rate of rebleeding, need for blood transfusion, hospital stay, adverse effects, and mortality rate.

Placebo

Drug

Intravenous saline over 24-48 hours along with initial management of airway management, hemodynamic stabilization, octreotide analogue, PPI, antibiotics, and endoscopy to control UGIB in cirrhotic patients.

Patients will be followed up after 5 days and 6 weeks to assess the rate of rebleeding, need for blood transfusion, hospital stay, adverse effects, and mortality rate.

Primary outcomes

  1. Rebleeding rate

    Time frame: through study completion, an average of 1 year

    The rate of rebleeding and need for blood transfusion at 5 days and 6 weeks will be evaluated and compared across the groups.

Secondary outcomes

  1. Mortality rate

    Time frame: through study completion, an average of 1 year

    The mortality rates at 5 days and 6 weeks will be evaluated and compared across the groups.

  2. adverse effects

    Time frame: through study completion, an average of 1 year

    Drug adverse effects at 5 days and 6 weeks will be evaluated and compared across the groups.

Study contacts

Contact information is provided by the study sponsor or research team.

Mennat-Allah M El Sawaf, MD

CONTACT

[email protected]

00201225548976

Rania M Elkafoury, MD

CONTACT

[email protected]

+201004672358

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Official study title

Efficacy of Tranexamic Acid and Vitamin k Injection in Control of Upper Gastrointestinal Bleeding in Egyptian Cirrhotic Patients: A Randomized Controlled Study

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Mar 18, 2025
Registry last updated
Mar 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.