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

Phase 4

Completed

• Conditions: Variceal Bleeding
• Interventions: Drug: Vitamin K1

• Registration Number: NCT06839352
• Lead Sponsor: Zagazig University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-10-03
• Primary Completion: 2023-10-19
• Study Completion: 2024-12-30
• Study First Submitted: 2025-01-27
• Status Verified: 2025-02
• Study First Submitted QC: 2025-02-16
• Last Update Submitted: 2025-02-16
• Study First Posted: 2025-02-21
• Last Update Posted: 2025-02-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 66

Inclusion Criteria

• Active acute upper gastrointestinal bleeding suspected of being of variceal origin (e.g., melena and/or hematemesis within 24 hours before inclusion) and required admission to the ICU.
• Endoscopic confirmation of variceal bleeding, carried out within twelve to twenty-four hours of ICU admission, was defined by either direct visualization of blood from a gastric or esophageal varix or the presence of red color signs on varices along with blood in the stomach or esophagus, with no other identifiable bleeding source.
• Cirrhosis has been confirmed through histology or by clear clinical, endoscopic, or sonographic signs of portal hypertension and cirrhosis.

Exclusion Criteria

• Known hypersensitivity to Vit-K1.
• Known hypercoagulopathy.
• Recent history (within 6 months) including deep vein thrombosis or pulmonary embolism.
• History of persistent or unstable angina pectoris, portal vein thrombosis, intermittent claudication, myocardial infarction, ischemic stroke, transient ischemic attack.
• Prior parenteral or oral Vit-K1 administration within the previous two weeks.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vitamin K1	Vitamin K1	-

Primary Outcome Measures

Name	Time	Method
Number of patients failed to control bleeding	1st 6 hours - from 6 to 24hours - from 24 hours to 5 days
Number of patients with rebleeding	within 5 days
Number and percent of mortality	5 days

Secondary Outcome Measures

Name	Time	Method
Median (IQR) of length of ICU staying	7 days
Median (IQR) of length of hospital stay	14 days

Trial Locations

Locations (1)

Zagazig University Hospital; 🇪🇬 Zagazig, Sharkia, Egypt