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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Age ≥18 years

• Liver cirrhosis

• Upper gastrointestinal bleeding

Locations
Other Locations
Egypt
Tanta University Hospitals
RECRUITING
Tanta
Contact Information
Primary
Rania M Elkafoury, MD
rania.elkafoury@med.tanta.edu.eg
+201004672358
Backup
Mennat-Allah M El Sawaf, MD
mennaallah.elsawaf@med.tanta.edu.eg
00201225548976
Time Frame
Start Date: 2024-12-02
Estimated Completion Date: 2025-12-30
Participants
Target number of participants: 194
Treatments
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.
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.
Related Therapeutic Areas
Sponsors
Leads: Tanta University

This content was sourced from clinicaltrials.gov