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

Phase 4

Recruiting

• Conditions: Upper Gastrointestinal Bleeding (UGIB); Variceal Bleeding; Cirrhosis
• Interventions: Drug: Tranexamic Acid and vitamin K; Drug: Placebo

• Registration Number: NCT06881628
• Lead Sponsor: Tanta University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-12-02
• Status Verified: 2025-03
• Study First Submitted: 2025-03-04
• Study First Submitted QC: 2025-03-11
• Last Update Submitted: 2025-03-11
• Study First Posted: 2025-03-18
• Last Update Posted: 2025-03-18
• Primary Completion: 2025-12-15
• Study Completion: 2025-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 194

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tranexamic acid and vitamin K	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.
Placebo	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.

Primary Outcome Measures

Name	Time	Method
Rebleeding rate	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 Outcome Measures

Name	Time	Method
Mortality rate	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.
adverse effects	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.

Trial Locations

Locations (1)

Tanta University Hospitals; 🇪🇬 Tanta, Gharbyea, Egypt