Efficacy of Tranexamic Acid and Vitamin K Injection in Controlling Upper Gastrointestinal Bleeding in Egyptian Cirrhotic Patients: A Randomized Controlled Study

What this Trial Is About

Researchers are evaluating the effectiveness of tranexamic acid combined with vitamin K injection compared to placebo in controlling upper gastrointestinal bleeding (UGIB) in patients with liver cirrhosis. The study aims to compare bleeding and mortality rates at 5 days and 6 weeks after endoscopic intervention. This randomized controlled trial focuses on Egyptian cirrhotic patients experiencing variceal bleeding, assessing key outcomes related to bleeding control and survival. Participants will be randomly assigned to receive either tranexamic acid (1 g loading dose followed by 3 g maintenance dose over 24-48 hours) with daily intravenous vitamin K (10 mg for 24-48 hours) or a matching placebo (intravenous saline) alongside standard care. Standard care includes airway management, hemodynamic stabilization, octreotide analogue, proton pump inhibitors, antibiotics, and endoscopy. Both groups will receive these interventions during the initial hospitalization. All patients will remain hospitalized for at least 5 days following the bleeding event and will be discharged if no complications arise. They will be monitored for rebleeding rates, the need for blood transfusion, hospital stay length, adverse effects, and mortality. After discharge, patients will start nonselective beta-blockers if appropriate and will be instructed to seek care if signs of bleeding recur. A follow-up visit at 6 weeks will evaluate rebleeding and mortality related to bleeding. The primary outcome is rebleeding rate up to one year, with mortality and adverse effects also tracked over the same period.

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