Portal Hypertension Related to CirrhosisBLEED-OUTcomesNCT07870850
Clinical Outcomes in Patients Presenting With Acute Variceal Bleeding
An observational study of Portal Hypertension Related to Cirrhosis and Variceal Bleeding, run by Institutul Regional de Gastroenterologie & Hepatologie Prof. dr. Octavian Fodor at 1 site in Romania.
Trial summary
The goal of this observational study is to learn about the outcomes of patients presenting with acute variceal bleeding and treated by endoscopic intervention. Rebleeding rates and mortality rates will be compared between patients perfoming endoscopy at different predefined times. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Portal Hypertension Related to Cirrhosis, Variceal Bleeding, Cirrhoses, Liver
- How many people
- 149 participants
- Where
- 1 siteRomania
- Study dates
- 1 Jan 2023to 30 Sep 2026
- Phase
- Observational
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients presenting with hematemesis, melena or hematochezia in a tertiary medical center in Cluj-Napoca, Romania
Who may be able to join
- Age ≥ 18 years
- Admission via emergency department with signs of UGIB (hematemesis, melena, hematochezia)
- Diagnosis of cirrhosis or clinical/imaging evidence of portal hypertension
- Endoscopic confirmation of esophageal or gastric varices as the bleeding source
- Upper endoscopy performed during the same hospital presentation
Who cannot join
- Non-variceal source of bleeding
- History of AVB within the previous 3 months
- Patients transferred after initial endoscopic management elsewhere
- Missing key timing or outcome data
Trial locations and contacts
1 site in 1 country.
Romania1 site
Regional Institute of Gastroenterology and Hepatology "Prof. Dr. Octavian Fodor"
Cluj-Napoca, 400158
About this study
Official title: Outcomes, Risk Factors for Rebleeding, and Mortality in Acute Variceal Bleeding: A Retrospective Cohort Study
The goal of this observational study is to learn about the outcomes of patients presenting with acute variceal bleeding and treated by endoscopic intervention. Rebleeding rates and mortality rates will be compared between patients perfoming endoscopy at different predefined times.
Read the detailed description
Following inclusion and exclusion criteria, after patients enrollement, data will be collected retrospectively from electronic medical records and include:
Baseline Characteristics:
Age, sex Etiology of liver disease Child-Pugh score MELD score (if available)
Clinical Data:
Hemodynamic status at admission (SBP) Laboratory values (Hb, INR, PT, platelets, creatinine, Na, fibrinogen, seric albumin, CRP) Presence of ascites or encephalopathy Comorbidities Hepatocellular carcinoma Portal vein thrombosis Timing of endoscopy Type of endoscopic intervention (EVL, cyanoacrylate) Pharmacologic therapy (vasoactive agents, antibiotics) Blood transfusion requirements
Statistical Analysis Plan Continuous variables will be expressed as mean ± SD or median (IQR), categorical variables as frequencies and percentages. Comparisons will be tested using ANOVA / Kruskal-Wallis for continuous variables, and Chi-square / Fisher's exact test for categorical variables.
Mortality rates will be calculated using, Kaplan-Meier survival curves and compared using Log-rank test.
Multivariate Analysis Logistic regression will be performed for assessing predictors for rebleeding and mortality.
Sample size calculation: all eligible patients meeting inclusion criteria during the study period will be included. No formal sample size calculation is required due to retrospective design. The estimated cohort sample is ~140 patients. Assuming a moderate effect size (Cohen's d = 0.5), a significance level (α) of 0.05, and a two-tailed test, a total sample size of 140 patients provides an estimated statistical power of approximately 80% to detect significant differences between groups.
- Keywords
- Acute variceal bleeding; cirrhosis; endoscopy timing; rebleeding; mortality; portal hypertension
- Medical subject headings
- Fibrosis, Hypertension, Portal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Urgent endoscopy group | Patient receiving endoscopic treatment within 6 hours from the presentation to the emergency room | |
| Early endoscopy group | Patient receiving endoscopic treatment between 6 and 12 hours from the presentation to the emergency room |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rebleeding rates
Rebleeding rates will be assessed and compared within each group
Measured: Up to six months
Mortality rates
Bleeding related mortality and overall mortality (at the end of follow-up) will be assessed and compared within groups
Measured: Up to six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2026
- Study start1 Jan 2023
- Primary completion20 May 2026
- Study completion30 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Portal Hypertension Related to CirrhosisStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 149 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institutul Regional de Gastroenterologie & Hepatologie Prof. dr. Octavian Fodor
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrada Seicean, Institutul Regional de Gastroenterologie & Hepatologie Prof. dr. Octavian Fodor
- Investigators
- Andrada Seicean, professor, Principal investigator, Iuliu Hatieganu University of Medicine and Pharmacy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07870850
- Sponsor's protocol ID
- 3755
- Acronym
- BLEED-OUTcomes
- Status last verified
- Oct 2026
- First submitted
- 29 Apr 2026
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: only IPD used in the results publication can be shared
Publications
Tripathi D, Stanley AJ, Hayes PC, Patch D, Millson C, Mehrzad H, Austin A, Ferguson JW, Olliff SP, Hudson M, Christie JM; Clinical Services and Standards Committee of the British Society of Gastroenterology. U.K. guidelines on the management of variceal haemorrhage in cirrhotic patients. Gut. 2015 Nov;64(11):1680-704. doi: 10.1136/gutjnl-2015-309262. Epub 2015 Apr 17.
PubMed 25887380Peng M, Bai Z, Zou D, Xu S, Wang C, Basaranoglu M, Philips CA, Guo X, Shao X, Qi X. Timing of endoscopy in patients with cirrhosis and acute variceal bleeding: a single-center retrospective study. BMC Gastroenterol. 2023 Jun 26;23(1):219. doi: 10.1186/s12876-023-02766-8.
PubMed 37365510Lesmana CRA, Shukla A, Kumar A, Shalimar, Qi X, Gani RA, Zhuang ZH, Dokmeci AK, Lo GH, Maruyama H, Jia JD, Kulkarni AV, Chang J, Ormeci N, Shiha G, Shah HA, Sollano JD, Rathi S, Siam TS, Lau GK, Rerknimitr R, Hou MC, Kurniawan J, Han G, Mukund A, Baijal SS, Sarin SK. Management of acute variceal bleeding: updated APASL guidelines. Hepatol Int. 2025 Oct;19(5):1003-1031. doi: 10.1007/s12072-025-10894-4. Epub 2025 Aug 31.
PubMed 40886248Yan X, Leng Z, Xu Q, Zhang Z, Xu M, Li J. The influences of timing of urgent endoscopy in patients with acute variceal bleeding: a cohort study. BMC Gastroenterol. 2022 Dec 8;22(1):506. doi: 10.1186/s12876-022-02595-1.
PubMed 36482309Jobe K, Henry Z. Endoscopic Treatment of Acute Esophageal and Gastric Variceal Bleeding. Gastrointest Endosc Clin N Am. 2024 Apr;34(2):249-261. doi: 10.1016/j.giec.2023.09.004. Epub 2023 Sep 26.
PubMed 38395482
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcomes, Risk Factors for Rebleeding, and Mortality in Acute Variceal Bleeding: A Retrospective Cohort Study
- ClinicalTrials.gov ID
- NCT07870850
- Acronym / sponsor ID
- BLEED-OUTcomes / 3755
- Keywords
- Acute variceal bleeding; cirrhosis; endoscopy timing; rebleeding; mortality; portal hypertension
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 149 participants (actual)
- Lead sponsor
- Institutul Regional de Gastroenterologie & Hepatologie Prof. dr. Octavian FodorUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 20 May 2026 (actual)
- Study completion
- 30 Sep 2026 (actual)
- First posted
- 13 Oct 2026 (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 goal of this observational study is to learn about the outcomes of patients presenting with acute variceal bleeding and treated by endoscopic intervention. Rebleeding rates and mortality rates will be compared between patients perfoming endoscopy at different predefined times.
Detailed description
Following inclusion and exclusion criteria, after patients enrollement, data will be collected retrospectively from electronic medical records and include:
Baseline Characteristics:
Age, sex Etiology of liver disease Child-Pugh score MELD score (if available)
Clinical Data:
Hemodynamic status at admission (SBP) Laboratory values (Hb, INR, PT, platelets, creatinine, Na, fibrinogen, seric albumin, CRP) Presence of ascites or encephalopathy Comorbidities Hepatocellular carcinoma Portal vein thrombosis Timing of endoscopy Type of endoscopic intervention (EVL, cyanoacrylate) Pharmacologic therapy (vasoactive agents, antibiotics) Blood transfusion requirements
Statistical Analysis Plan Continuous variables will be expressed as mean ± SD or median (IQR), categorical variables as frequencies and percentages. Comparisons will be tested using ANOVA / Kruskal-Wallis for continuous variables, and Chi-square / Fisher's exact test for categorical variables.
Mortality rates will be calculated using, Kaplan-Meier survival curves and compared using Log-rank test.
Multivariate Analysis Logistic regression will be performed for assessing predictors for rebleeding and mortality.
Sample size calculation: all eligible patients meeting inclusion criteria during the study period will be included. No formal sample size calculation is required due to retrospective design. The estimated cohort sample is ~140 patients. Assuming a moderate effect size (Cohen's d = 0.5), a significance level (α) of 0.05, and a two-tailed test, a total sample size of 140 patients provides an estimated statistical power of approximately 80% to detect significant differences between groups.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Urgent endoscopy group | – | –Patient receiving endoscopic treatment within 6 hours from the presentation to the emergency room |
| Early endoscopy group | – | –Patient receiving endoscopic treatment between 6 and 12 hours from the presentation to the emergency room |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients presenting with hematemesis, melena or hematochezia in a tertiary medical center in Cluj-Napoca, Romania
Key inclusion criteria (5 listed)
- Age ≥ 18 years
- Admission via emergency department with signs of UGIB (hematemesis, melena, hematochezia)
- Diagnosis of cirrhosis or clinical/imaging evidence of portal hypertension
- Endoscopic confirmation of esophageal or gastric varices as the bleeding source
- Upper endoscopy performed during the same hospital presentation
Key exclusion criteria (4 listed)
- Non-variceal source of bleeding
- History of AVB within the previous 3 months
- Patients transferred after initial endoscopic management elsewhere
- Missing key timing or outcome data
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Rebleeding rates
Time frame: Up to six months
Rebleeding rates will be assessed and compared within each group
Mortality rates
Time frame: Up to six months
Bleeding related mortality and overall mortality (at the end of follow-up) will be assessed and compared within groups
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 13 Oct 2026.
- Background: PubMed 25887380Tripathi D, Stanley AJ, Hayes PC, Patch D, Millson C, Mehrzad H, Austin A, Ferguson JW, Olliff SP, Hudson M, Christie JM; Clinical Services and Standards Committee of the British Society of Gastroenterology. U.K. guidelines on the management of variceal haemorrhage in cirrhotic patients. Gut. 2015 Nov;64(11):1680-704. doi: 10.1136/gutjnl-2015-309262. Epub 2015 Apr 17.
- Background: PubMed 37365510Peng M, Bai Z, Zou D, Xu S, Wang C, Basaranoglu M, Philips CA, Guo X, Shao X, Qi X. Timing of endoscopy in patients with cirrhosis and acute variceal bleeding: a single-center retrospective study. BMC Gastroenterol. 2023 Jun 26;23(1):219. doi: 10.1186/s12876-023-02766-8.
- Background: PubMed 40886248Lesmana CRA, Shukla A, Kumar A, Shalimar, Qi X, Gani RA, Zhuang ZH, Dokmeci AK, Lo GH, Maruyama H, Jia JD, Kulkarni AV, Chang J, Ormeci N, Shiha G, Shah HA, Sollano JD, Rathi S, Siam TS, Lau GK, Rerknimitr R, Hou MC, Kurniawan J, Han G, Mukund A, Baijal SS, Sarin SK. Management of acute variceal bleeding: updated APASL guidelines. Hepatol Int. 2025 Oct;19(5):1003-1031. doi: 10.1007/s12072-025-10894-4. Epub 2025 Aug 31.
- Background: PubMed 36482309Yan X, Leng Z, Xu Q, Zhang Z, Xu M, Li J. The influences of timing of urgent endoscopy in patients with acute variceal bleeding: a cohort study. BMC Gastroenterol. 2022 Dec 8;22(1):506. doi: 10.1186/s12876-022-02595-1.
- Background: PubMed 38395482Jobe K, Henry Z. Endoscopic Treatment of Acute Esophageal and Gastric Variceal Bleeding. Gastrointest Endosc Clin N Am. 2024 Apr;34(2):249-261. doi: 10.1016/j.giec.2023.09.004. Epub 2023 Sep 26.
- Individual participant dataSharing planned: Undecided. only IPD used in the results publication can be shared
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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.
Andrada Seicean, professor principal investigator
Iuliu Hatieganu University of Medicine and Pharmacy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Portal Hypertension Related to Cirrhosis and Variceal Bleeding, run by Institutul Regional de Gastroenterologie & Hepatologie Prof. dr. Octavian Fodor at 1 site in Romania.
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 5 inclusion and 4 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 13 Oct 2026. 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 Romania. 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.
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?
Rebleeding rates (time frame: Up to six months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07870850, which also lists 5 linked publications.
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 13 Oct 2026.