NCT06839352

Efficacy and Safety of Intravenous Vitamin K1 in Management of Acute Variceal Bleeding

Assessment of Efficacy and Safety of Intravenous Vitamin K1 in Management of Acute Variceal Bleeding in Patients With Liver Cirrhosis: A Randomized Open Label Clinical Trial

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 66 (actual)
• Sponsor: Zagazig University · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The administration of Vitamin K1 (Vit-K1) injection is frequently utilized in clinical practice for managing upper gastrointestinal bleeding (UGIB) associated with liver cirrhosis, despite insufficient evidence supporting its effectiveness. This research aimed to assess the safety and efficacy of intravenous Vit-K1 in the management of acute variceal bleeding in cirrhotic patients. This randomized, open-label clinical trial involved 66 cirrhotic cases with UGIB of suspected variceal origin. The cases were randomly assigned to two groups: one group (n = 33) had a 10 mg intravenous infusion of Vit-K1 daily for three days, while the other group (n = 33) received nothing, along with standard pharmacologic and endoscopic treatments. Endoscopic evaluation confirmed ruptured varices as the cause of bleeding in 59 cases. The primary endpoint was a composite measure that involved (bleeding control, rebleeding prevention, or death). Adding vitamin K1 to standard-of-care therapy in managing acute variceal bleeding complicating liver cirrhosis showed no advantage over standard-of-care therapy in terms of bleeding control, prevention of rebleeding, or reducing mortality during hospital stay.

Conditions

• Variceal Bleeding

Interventions

Type	Name	Description
DRUG	Vitamin K1	10 mg intravenous infusion daily for three days

Timeline

• Start date: 2022-10-03
• Primary completion: 2023-10-19
• Completion: 2024-12-30
• First posted: 2025-02-21
• Last updated: 2025-02-21

Locations

1 site across 1 country: Egypt