Trial · Interventional

TerminatedPhase 4Results postedRegistry data

Comparison of 24-hours Versus 72-hours of Octreotide Infusion in Preventing Early Rebleed From Esophageal Varices

Short name LOVARB

NCTNCT03624517Other idPro00027015

Open at ClinicalTrials.govAsk about this trial

This trial was stopped early.

Reason given at the registry: Recruitment was severely affected due to COVID, so study was stopped prematurely.

Results were posted for this trial.

Overview

Status: Terminated
Phase: Phase 4
Enrollment: 34 participants (actual)
Sponsor: Medical University of South Carolina · Other
Design: Randomized · Single masking
Countries: 1 country
United States
Start: 19 Sept 2018
Primary completion: 1 Dec 2024
Completion: 1 Dec 2024
First posted: 10 Aug 2018
Last update posted: 20 Nov 2025
Conditions: Esophageal Varices · Liver Cirrhoses · Bleeding Esophageal Varices · Upper Gastrointestinal Bleeding

Timeline

1 trial · 1 stopped early · 1 with posted results

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

2018202020222024

Ph 4
LOVARB
NCT03624517
19 Sept 2018 to 1 Dec 2024
Terminated
Terminated

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

This study evaluates the safety and efficacy of 24-hour vs 72-hour octreotide infusion after variceal banding in cirrhotic patients with bleeding esophageal varices.

Interventions

OctreotideDrug

Arms2

Experimental
24-hour octreotide infusion
Patients will receive octreotide infusion over 24 hours
Active comparator
72-hour octreotide infusion
Patients will receive octreotide infusion over 72 hours

Primary outcomes1

Outcomes the sponsor listed as primary.

Esophageal Varices Rebleed Within 72-hours After Control of Initial Bleed
Time frame · 72 hours
Registry description
Rebleeding within 72-hours will be defined as any of the following: 1. A drop in hemoglobin by more than 20 percentage points from baseline 2. Sustained tachycardia above 100 beats per minute, with or without hematochezia or melena 3. Transfusion of \>2 unites packed red blood cells after esophageal band ligation 4. Recurrence of hematemesis or ongoing melena 5. Urgent or emergent need for Transjugular Intrahepatic Portosystemic Shunt (TIPS) to control suspected rebleeding

Secondary outcomes(2)

Esophageal Varices Rebleed at 7 Days and 30 Days After Control of Initial Bleed
Time frame · 7 days and 30 days
Registry description
Rebleeding after 72-hours will be defined as: 1. Any new episode of hematemesis, melena, or hematochezia (with hemodynamic instability) 2. Drop in hemoglobin by more than 20 percentage points OR the need for \>2 units packed red blood cells 3. Need for TIPS or surgery to control suspected bleeding
Survival at 7 Days and 30 Days After Control of Initial Bleed
Time frame · 7 days and 30 days
Registry description
Survival at 7 days and 30 days.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeCount of participants· 72 hours

Esophageal Varices Rebleed Within 72-hours After Control of Initial Bleed

Group	Value (Participants)
24-hour octreotide infusion	0
72-hour octreotide infusion	1

Secondary and other outcome results(2)

Secondary outcomeCount of participants· 7 days and 30 days

Esophageal Varices Rebleed at 7 Days and 30 Days After Control of Initial Bleed

Group	Value (Participants)
24-hour octreotide infusion	0
72-hour octreotide infusion	1

Secondary outcomeCount of participants· 7 days and 30 days

Survival at 7 Days and 30 Days After Control of Initial Bleed

Group	Value (Participants)
24-hour octreotide infusion	15
72-hour octreotide infusion	19

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
Group	Deaths	Serious events	Other events
24-hour octreotide infusionPatients will receive octreotide infusion over 24 hours Octreotide: Octreotide infusion for 24-hours in patients with bleeding esophageal varices.	0 / 15	0 / 15	2 / 15
72-hour octreotide infusionPatients will receive octreotide infusion over 72 hours Octreotide: Octreotide infusion for 24-hours in patients with bleeding esophageal varices.	1 / 19	1 / 19	8 / 19

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

More studies

1 study on this page

Indexing hint: Randomized controlled trial · 2025

Comparison of 24 vs 72-hr octreotide infusion in acute esophageal variceal hemorrhage - A multi-center, randomized clinical trial.

Allam et al. 2025The American journal of the medical sciencescited by 4

PMID 39241828PMC11700778DOI 10.1016/j.amjms.2024.08.027PUB-39241828

Rights unknown

Source link

Eligibility

Who could join, as posted.

Sex: All
Age: from 18 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

Inclusion Criteria: 1. Adult males and females who are 18 years of age or older. 2. Evidence or suspicion of upper gastrointestinal bleed (GIB) 3. Patient with known or suspected cirrhosis 4. Upper GIB secondary to bleeding esophageal varices as show by esophageal endoscopy, requiring endoscopic band ligation (EBL) at presentation 5. Willing and able to provide informed consent for study, or have a Legally authorized representative (LAR) provide consent if the patient is unable to do so Exclusion Criteria: 1. Known upper gastrointestinal malignancy 2. Bleeding from gastric varices, with or without esophageal varices 3. Use of any other endoscopic method to stop GI bleeding beyond endoscopic band ligation 4. Variceal bleeding in the last 90 days 5. History of transjugular, intrahepatic, portosystemic shunt (TIPS) or vascular decompression surgery 6. Pregnant females 7. Incarcerated individuals 8. Myocardial infarct, cerebrovascular accident, sepsis, respiratory failure, or severe intercurrent illness within the previous 6 weeks 9. Non-cirrhotic portal hypertension causing esophageal varices 10. Known or suspected allergy to octreotide

PepBank is a research reference. Talk to a doctor before you use any peptide.