Clinical trial NCT06881628: Tranxemic Acid and Vitamin K Injection to Control Upper Gastrointestinal Bleeding in Cirrhotic Patients
Official title: Efficacy of Tranexamic Acid and Vitamin k Injection in Control of Upper Gastrointestinal Bleeding in Egyptian Cirrhotic Patients: A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Upper Gastrointestinal Bleeding (UGIB)
Variceal Bleeding
Cirrhosis
Keywords: Variceal bleeding
Tranexamic acid and vitamin K
Liver cirrhosis
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2025-03-18
Enrollment: 194
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Rebleeding rate
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: Mortality rate
timeFrame: through study completion, an average of 1 year
measure: adverse effects
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Tanta University Hospitals
state: Gharbyea
Study officials:
affiliation: Tropical medicine and infectious diseases Department, Faculty of Medicine, Tanta University
name: Rania M Elkafoury, MD
role: PRINCIPAL_INVESTIGATOR
References: