Variceal Bleeding
Conditions
Keywords
Vitamin K1, Liver cirrhosis, Esophageal and gastric varices, Upper gastrointestinal bleeding
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.
Interventions
DRUGVitamin K1
10 mg intravenous infusion daily for three days
Sponsors
Zagazig University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Median (IQR) of length of ICU staying | 7 days |
| Median (IQR) of length of hospital stay | 14 days |
Countries
Egypt
Outcome results
None listed