Tranexamic acid and vitamin K for upper digestive tract bleeding in cirrhosis
Tests tranexamic acid with vitamin K against placebo in cirrhosis patients with variceal bleeding.
Key facts
- Who runs it
- Tanta University
- Where
- Egypt1 site in 1 countryChoose a country to see its sites
- Trial code
- Registry title
- Tranxemic Acid and Vitamin K Injection to Control Upper Gastrointestinal Bleeding in Cirrhotic Patients
- Status
- Recruiting
- Phase
- Phase 4
- People taking part
- 194 people, planned
- Started
- 2 Dec 2024
- Planned end
- 30 Dec 2025
- Type of study
- Interventional, 2 groupsOne group gets a placebo (a dummy treatment), for comparison.
- Treatments tested
- Tranexamic Acid and vitamin K
- Placebo
- Record updated
- 18 March 2025
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with liver cirrhosis who have bleeding in the upper digestive tract. It compares tranexamic acid with vitamin K against a placebo (salt water).
- Age
- 18 years or older
- Sex
- All sexes
- Disease stage
- Liver cirrhosis with upper gastrointestinal bleeding, such as bleeding from swollen veins (varices)
Main reasons for not taking part
- Allergy to tranexamic acid or to vitamin K injection
- DIC, a serious blood clotting disorder
- A blood clot event (thromboembolic event)
- Pregnancy or breastfeeding
- End-stage kidney disease
The registry criteria, word for word
Show all 11 criteriaShow less
Who can take part
- Age ≥18 years
- Liver cirrhosis
- Upper gastrointestinal bleeding
Who cannot take part
- Allergy to tranexamic acid
- Allergy to vitamin K injection
- End-stage renal disease
- Patients aged < 18 years
- DIC
- Thromboembolic event
- Pregnancy or lactation
- Unwilling to participate in our study
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
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.
Read full original descriptionShow less
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.
The 2 groups in the trial
- Tranexamic acid and vitamin KTreatment being tested
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.
- PlaceboPlacebo, for comparison
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.
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Efficacy of Tranexamic Acid and Vitamin k Injection in Control of Upper Gastrointestinal Bleeding in Egyptian Cirrhotic Patients: A Randomized Controlled Study
- Plain-language title
- Tranexamic acid and vitamin K for upper digestive tract bleeding in cirrhosisGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 14 November 2026.
- Record updated
- 18 March 2025