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Tranxemic Acid and Vitamin K Injection to Control Upper Gastrointestinal Bleeding in Cirrhotic Patients

RecruitingPhase 4Ages 18 Years - anyAllTanta University
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In plain words

What the trial is, and whether it could suit you

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 endo

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📋 Eligibility rules (as published)
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.
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What it tests

  • Tranexamic Acid and vitamin K
  • Placebo
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Where

1 site
Tanta University Hospitals
Tanta, Egypt
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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