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

NCT06881628 | Recruiting Phase 4

• 1 other identifier: 36264PR982/12/24
• Study Type: interventional
• Target: 194
• Locations: 1 country
• Sites: 1

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

Keywords

Variceal bleeding; Tranexamic acid and vitamin K; Liver cirrhosis

Outcome Measures

Primary Outcomes (1)

• Rebleeding rate

  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 Outcomes (2)

• Mortality rate

  through study completion, an average of 1 year

• adverse effects

  through study completion, an average of 1 year

Study Arms (2)

Tranexamic acid and vitamin K

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

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

Interventions

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.

Tranexamic acid and vitamin K

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.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Tanta University Hospitals

Tanta, Gharbyea, 31516, Egypt

RECRUITING

MeSH Terms

Conditions

Gastrointestinal Hemorrhage; Fibrosis; Liver Cirrhosis

Interventions

Tranexamic Acid; Vitamin K

Condition Hierarchy (Ancestors)

Gastrointestinal Diseases; Digestive System Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Liver Diseases

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Naphthoquinones; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Phytol; Diterpenes; Terpenes; Polycyclic Compounds

Study Officials

• Rania M Elkafoury, MD

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rania M Elkafoury, MD

CONTACT

+201004672358; rania.elkafoury@med.tanta.edu.eg

Mennat-Allah M El Sawaf, MD

CONTACT

00201225548976; mennaallah.elsawaf@med.tanta.edu.eg

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Tropical Medicine

Study Record Dates

• First Submitted: March 4, 2025
• First Posted: March 18, 2025
• Study Start: December 2, 2024
• Primary Completion: December 15, 2025
• Study Completion: December 30, 2025
• Last Updated: March 18, 2025

Record last verified: 2025-03

Locations

EG (1)