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

NCT06839352 | Completed Phase 4

• 1 other identifier: ZU-IRB#9092/16-11-2021
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

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

Keywords

Vitamin K1; Liver cirrhosis; Esophageal and gastric varices; Upper gastrointestinal bleeding

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• Median (IQR) of length of ICU staying

  7 days

• Median (IQR) of length of hospital stay

  14 days

Study Arms (2)

Vitamin K1

ACTIVE COMPARATOR

Drug: Vitamin K1

Control

NO INTERVENTION

Interventions

Vitamin K1 DRUG

10 mg intravenous infusion daily for three days

Vitamin K1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zagazig University: lead

Study Sites (1)

Zagazig University Hospital

Zagazig, Sharqia Province, 44519, Egypt

Location

MeSH Terms

Conditions

Liver Cirrhosis; Esophageal and Gastric Varices; Gastrointestinal Hemorrhage

Interventions

Vitamin K 1

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Esophageal Diseases; Gastrointestinal Diseases; Hypertension, Portal; Hemorrhage

Intervention Hierarchy (Ancestors)

Vitamin K; Naphthoquinones; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Phytol; Diterpenes; Terpenes; Quinones; Polycyclic Compounds

Study Officials

• Ayman Sadek, MD

  Zagazig University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Internal Medicine

Study Record Dates

• First Submitted: January 27, 2025
• First Posted: February 21, 2025
• Study Start: October 3, 2022
• Primary Completion: October 19, 2023
• Study Completion: December 30, 2024
• Last Updated: February 21, 2025

Record last verified: 2025-02

Locations

EG (1)