NCT06881628 Tranxemic Acid and Vitamin K Injection to Control Upper Gastrointestinal Bleeding in Cirrhotic Patients
| NCT ID | NCT06881628 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Tanta University |
| Condition | Upper Gastrointestinal Bleeding (UGIB) |
| Study Type | INTERVENTIONAL |
| Enrollment | 194 participants |
| Start Date | 2024-12-02 |
| Primary Completion | 2025-12-15 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 194 participants in total. It began in 2024-12-02 with a primary completion date of 2025-12-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Contact & Investigator
Rania M Elkafoury, MD
PRINCIPAL INVESTIGATOR
Tropical medicine and infectious diseases Department, Faculty of Medicine, Tanta University
Frequently Asked Questions
Who can join the NCT06881628 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Upper Gastrointestinal Bleeding (UGIB). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06881628 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06881628 currently recruiting?
Yes, NCT06881628 is actively recruiting participants. Contact the research team at rania.elkafoury@med.tanta.edu.eg for enrollment information.
Where is the NCT06881628 trial being conducted?
This trial is being conducted at Tanta, Egypt.
Who is sponsoring the NCT06881628 clinical trial?
NCT06881628 is sponsored by Tanta University. The principal investigator is Rania M Elkafoury, MD at Tropical medicine and infectious diseases Department, Faculty of Medicine, Tanta University. The trial plans to enroll 194 participants.