NCT06839352CompletedPhase 4
Efficacy and Safety of Intravenous Vitamin K1 in Management of Acute Variceal Bleeding
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
Source: ClinicalTrials.gov · Last updated 21 Feb 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 66 (actual)
- First submitted
- 27 Jan 2025
- Start date
- 3 Oct 2022
- Primary completion date
- 19 Oct 2023
- Lead sponsor
- Zagazig University
- NCT number
- NCT06839352
What you commit to
- Study type: Interventional · Phase 4
- Participants enrolled: 66
- From 3 Oct 2022 to the primary completion date, 19 Oct 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior parenteral or oral Vit-K1 administration within the previous two weeks.
Other illness
- Known hypersensitivity to Vit-K1.
- 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.
Other
- Known hypercoagulopathy.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Zagazig University Hospital Coordinator of this site? Confirm its status | Zagazig | Egypt | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.