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

NCT ID: NCT06839352

Last Updated: 2025-02-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 66 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-03
• Study Completion Date: 2024-12-30

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.

Conditions

Variceal Bleeding

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Vitamin K1

Group Type: ACTIVE_COMPARATOR

Vitamin K1

Intervention Type: DRUG

10 mg intravenous infusion daily for three days

Control

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Vitamin K1

10 mg intravenous infusion daily for three days

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zagazig University

OTHER_GOV

Sponsor Role: lead

Responsible Party

Ayman Magd Eldin Mohammad Sadek

Associate Professor of Internal Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ayman Sadek, MD

Role: STUDY_CHAIR

Zagazig University

Locations

Zagazig University Hospital

Zagazig, Sharqia Province, Egypt

Countries

Egypt

Other Identifiers

ZU-IRB#9092/16-11-2021

Identifier Type: -

Identifier Source: org_study_id