Clinical trial NCT06839352: Efficacy and Safety of Intravenous Vitamin K1 in Management of Acute Variceal Bleeding
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Variceal Bleeding
Keywords: Vitamin K1
Liver cirrhosis
Esophageal and gastric varices
Upper gastrointestinal bleeding
Lead sponsor: Zagazig University
Sponsor class: OTHER_GOV
First posted: 2025-02-21
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Number of patients failed to control bleeding
timeFrame: 1st 6 hours - from 6 to 24hours - from 24 hours to 5 days
measure: Number of patients with rebleeding
timeFrame: within 5 days
measure: Number and percent of mortality
timeFrame: 5 days
Secondary outcomes:
measure: Median (IQR) of length of ICU staying
timeFrame: 7 days
measure: Median (IQR) of length of hospital stay
timeFrame: 14 days
Other outcomes:
Locations:
city: Zagazig
country: Egypt
facility: Zagazig University Hospital
state: Sharkia
Study officials:
affiliation: Zagazig University
name: Ayman Sadek, MD
role: STUDY_CHAIR
References: