An observational study in Portal Hypertension Related to Cirrhosis, Variceal Bleeding and Cirrhoses, Liver, sponsored by Institutul Regional de Gastroenterologie & Hepatologie Prof. dr. Octavian Fodor. Completed at 1 site in Romania. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-10-13.
Sponsored by Institutul Regional de Gastroenterologie & Hepatologie Prof. dr. Octavian Fodor · Observational
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.
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.
3,274 studies on the registry are indexed under Fibrosis; 466 are open to participants now.
This study's enrollment of 149 is above the median of 112 across 984 observational studies indexed under Fibrosis.
Browse Fibrosis studies →Institutul Regional de Gastroenterologie & Hepatologie Prof. dr. Octavian Fodor is the lead sponsor of 7 studies on the registry; 2 are open to participants now.
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Patients presenting with hematemesis, melena or hematochezia in a tertiary medical center in Cluj-Napoca, Romania
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Patient receiving endoscopic treatment within 6 hours from the presentation to the emergency room
Patient receiving endoscopic treatment between 6 and 12 hours from the presentation to the emergency room
Rebleeding rates
Rebleeding rates will be assessed and compared within each group
Time frame: 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
Time frame: Up to six months
Documents are hosted by the registry — open the source record to download them.
Plan to share: Undecided — only IPD used in the results publication can be shared
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Institutul Regional de Gastroenterologie & Hepatologie Prof. dr. Octavian Fodor