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

March 11, 2025 updated by: Rania Mamdouh Elkafoury, Tanta University

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

194

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Egypt
    • Gharbyea
      • Tanta, Gharbyea, Egypt, 31516
        • Recruiting
        • Tanta University Hospitals
        • Contact:
        • Contact:
          • Rania M Elkafoury, MD
        • Contact:
          • Nabila A Elgazzar, MD
        • Contact:
          • Mennat-Allah M El Sawaf, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Tranexamic acid and vitamin K
97 cirrhotic patients presenting with UGIB receiving 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. Intervention will be carried out besides the recommended initial management of airway management, hemodynamic stabilization, octreotide analogue, PPI, antibiotics, and endoscopy.
Drug: Tranexamic Acid and vitamin K

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 Comparator: Placebo
97 cirrhotic patients presenting with UGIB receiving IV saline besides the recommended initial management of airway management, hemodynamic stabilization, octreotide analogue, PPI, antibiotics, and endoscopy.
Drug: Placebo

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
through study completion, an average of 1 year
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.
through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tanta University

Investigators

  • Principal Investigator: Rania M Elkafoury, MD, Tropical medicine and infectious diseases Department, Faculty of Medicine, Tanta University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 2, 2024

Primary Completion (Estimated)

December 15, 2025

Study Completion (Estimated)

December 30, 2025

Study Registration Dates

First Submitted

March 4, 2025

First Submitted That Met QC Criteria

March 11, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 11, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 36264PR982/12/24

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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