Using Tranexamic Acid and Vitamin K to Treat 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
Run by Tanta University · NCT06881628 · Data updated 2026-11-12
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 |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 194 (estimated) |
| Sponsor | Tanta University Academic / other |
| Locations | 1 site (Tanta, Gharbyea) |
| Status | Recruiting |
| Started | December 2, 2024 |
| Main results expected | December 15, 2025 |
| Study ends | December 30, 2025 |
| Registry record updated | March 18, 2025 |
| Trial ID | NCT06881628 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are adults aged 18 and older with liver cirrhosis and upper gastrointestinal bleeding.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
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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
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Endovascular treatment outcomes after portal hypertension–related GI bleeding in cirrhosis
This study tests how well endovascular procedures for portal hypertension–related GI bleeding work in adults with cirrhosis, and what factors predict outcomes.
-
EUS-guided coil and glue vs glue injection for bleeding gastric varices in cirrhosis
This trial tests whether using endoscopic ultrasound to guide coils plus glue works better than glue alone for stopping bleeding from gastric varices in adults with cirrhosis.
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4D-Flow MRI to see portal hypertension and TIPS outcomes in cirrhosis
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Apixaban plus carvedilol to prevent portal-hypertension complications in cirrhosis
This will test whether adding apixaban to carvedilol can help prevent variceal bleeding, portal vein thrombosis, and other portal-hypertension complications in adults with Child-Pugh B cirrhosis.
-
Factors that affect reopening of blocked portal veins in people with cirrhosis and gastroesophageal varices
This project looks at past records and follow-up to see which factors are linked with reopening (recanalization) of blocked portal veins in people who have cirrhosis and endoscopy-confirmed gastroesophageal varices.
-
Copper supplementation for people with cirrhosis
This trial will try giving copper supplements to adults with cirrhosis who have low copper levels or signs of copper deficiency to see if liver-related health improves.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.