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Completed

NCT Number: NCT06839352

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

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.

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Key information

Conditions

Variceal Bleeding Digestive System Diseases Esophageal Diseases Esophageal and Gastric Varices Fibrosis Gastrointestinal Diseases Gastrointestinal Hemorrhage Hemorrhage Hypertension, Portal Liver Cirrhosis Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Zagazig University Hospital

Zagazig, Sharqia Province, 44519, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Vitamin K1

Drug

10 mg intravenous infusion daily for three days

Primary outcomes

  1. Number of patients failed to control bleeding

    Time frame: 1st 6 hours - from 6 to 24hours - from 24 hours to 5 days

  2. Number of patients with rebleeding

    Time frame: within 5 days

  3. Number and percent of mortality

    Time frame: 5 days

Secondary outcomes

  1. Median (IQR) of length of ICU staying

    Time frame: 7 days

  2. Median (IQR) of length of hospital stay

    Time frame: 14 days

Sponsors and collaborators

Lead sponsor

Zagazig University

Other Gov

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2024
First posted
Feb 21, 2025
Registry last updated
Feb 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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