Variceal BleedingPhase 4NCT06839352
Efficacy and Safety of Intravenous Vitamin K1 in Management of Acute Variceal Bleeding
A Phase 4 study testing Vitamin K1 in people with Variceal Bleeding, run by Zagazig University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Variceal Bleeding
- What is being tested?
- Vitamin K1
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteEgypt
- Study dates
- 3 Oct 2022to 30 Dec 2024
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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
- Being tested
- Vitamin K1
- Keywords
- Vitamin K1, Liver cirrhosis, Esophageal and gastric varices, Upper gastrointestinal bleeding
- Medical subject headings
- Liver Cirrhosis, Esophageal and Gastric Varices, Gastrointestinal Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin K1Drug
10 mg intravenous infusion daily for three days
| Study group | Role | What they receive |
|---|---|---|
| Vitamin K1 | Active comparator | Not described Receives: Drug: Vitamin K1 |
| Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients failed to control bleeding
Measured: 1st 6 hours - from 6 to 24hours - from 24 hours to 5 days
Number of patients with rebleeding
Measured: within 5 days
Number and percent of mortality
Measured: 5 days
Secondary outcomes (2)
Median (IQR) of length of ICU staying
Measured: 7 days
Median (IQR) of length of hospital stay
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2025
- Study start3 Oct 2022
- Primary completion19 Oct 2023
- Study completion30 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Variceal BleedingStudies of the same condition, open and under way.
- More trials run by Zagazig UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zagazig University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Ayman Magd Eldin Mohammad Sadek, Zagazig University
- Investigators
- Ayman Sadek, MD, Study chair, Zagazig University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06839352
- Sponsor's protocol ID
- ZU-IRB#9092/16-11-2021
- Status last verified
- Feb 2025
- First submitted
- 27 Jan 2025
- Last updated
- 21 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06839352
- Acronym / sponsor ID
- ZU-IRB#9092/16-11-2021
- Conditions
- Variceal Bleeding
- Keywords
- Vitamin K1, Liver cirrhosis, Esophageal and gastric varices, Upper gastrointestinal bleeding
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Zagazig UniversityOther government
- Study start
- 3 Oct 2022 (actual)
- Primary completion
- 19 Oct 2023 (actual)
- Study completion
- 30 Dec 2024 (actual)
- First posted
- 21 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vitamin K1 | Active comparator | Drug: Vitamin K1 |
| Control | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vitamin K110 mg intravenous infusion daily for three days | Drug | Vitamin K1 |
Primary outcome
Number of patients failed to control bleeding
Time frame: 1st 6 hours - from 6 to 24hours - from 24 hours to 5 days
Number of patients with rebleeding
Time frame: within 5 days
Number and percent of mortality
Time frame: 5 days
2 secondary outcomes
Median (IQR) of length of ICU staying
Time frame: 7 days
Median (IQR) of length of hospital stay
Time frame: 14 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ayman Sadek, MD study chair
Zagazig University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Vitamin K1 in people with Variceal Bleeding, run by Zagazig University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients failed to control bleeding (time frame: 1st 6 hours - from 6 to 24hours - from 24 hours to 5 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2025; AzTrials last refreshed its copy on 8 Nov 2026.