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

NCT06839352 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 66

Last updated 2025-02-21

No results posted yet for this study

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

DRUG

Vitamin K1

10 mg intravenous infusion daily for three days

Sponsors & Collaborators

  • Zagazig University

    lead OTHER_GOV

Principal Investigators

  • Ayman Sadek, MD · Zagazig University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-10-03
Primary Completion
2023-10-19
Completion
2024-12-30

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06839352 on ClinicalTrials.gov