Using Tranexamic Acid and Vitamin K to Treat Upper Gastrointestinal Bleeding in Cirrhotic Patients
Efficacy of Tranexamic Acid and Vitamin k Injection in Control of Upper Gastrointestinal Bleeding in Egyptian Cirrhotic Patients: A Randomized Controlled Study
This study is testing whether giving Tranexamic acid and vitamin K can help control bleeding in the stomach for people with liver cirrhosis.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 194 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Tanta University Academic / other |
| Locations | 1 site (Tanta, Gharbyea) |
| Trial ID | NCT06881628 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to assess the effectiveness of Tranexamic acid and vitamin K injections in controlling upper gastrointestinal bleeding (UGIB) among Egyptian patients with liver cirrhosis. Participants experiencing variceal bleeding will be randomly assigned to receive either the active treatment or a placebo, with outcomes measured in terms of bleeding and mortality rates at 5 days and 6 weeks following endoscopic intervention. The study will also ensure that all patients receive standard initial management for their condition. The trial is designed to provide insights into the potential benefits of these interventions in a specific patient population.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older with liver cirrhosis and upper gastrointestinal bleeding.
Not a fit: Patients under 18 years old, those with allergies to the study medications, or those with certain medical conditions such as end-stage renal disease will not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly reduce bleeding and mortality rates in cirrhotic patients experiencing UGIB.
How similar studies have performed: While the specific combination of Tranexamic acid and vitamin K for this indication may be novel, similar studies have shown promise in using Tranexamic acid for bleeding control in various contexts.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Tanta, Gharbyea
- Tanta University Hospitals — Tanta, Gharbyea, Egypt (Recruiting)
Study contacts
- Principal investigator: Rania M Elkafoury, MD — Tropical medicine and infectious diseases Department, Faculty of Medicine, Tanta University
- Study coordinator: Rania M Elkafoury, MD
- Email: rania.elkafoury@med.tanta.edu.eg
- Phone: +201004672358
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.