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

NCT ID: NCT06881628

Last Updated: 2025-03-18

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 194 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-12-02
• Study Completion Date: 2025-12-30

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.

Conditions

Upper Gastrointestinal Bleeding (UGIB); Variceal Bleeding; Cirrhosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Tranexamic Acid and vitamin K

Intervention Type: 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

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.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tanta University

OTHER

Sponsor Role: lead

Responsible Party

Rania Mamdouh Elkafoury

Lecturer of Tropical Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Rania M Elkafoury, MD

Role: PRINCIPAL_INVESTIGATOR

Tropical medicine and infectious diseases Department, Faculty of Medicine, Tanta University

Locations

Tanta University Hospitals

Tanta, Gharbyea, Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Rania M Elkafoury, MD

Role: CONTACT

rania.elkafoury@med.tanta.edu.eg

+201004672358

Mennat-Allah M El Sawaf, MD

Role: CONTACT

mennaallah.elsawaf@med.tanta.edu.eg

00201225548976

Facility Contacts

Dina H Ziada, MD

Role: primary

dina.ziada@med.tanta.edu.eg

00201117109990

Other Identifiers

36264PR982/12/24

Identifier Type: -

Identifier Source: org_study_id