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

Comparison of 24-hours Versus 72-hours of Octreotide Infusion Along With Endoscopic Therapy in Preventing Early Rebleed From Esophageal Varices: a Multi-center, Randomized Clinical Study

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.

Study Overview

• Status: Terminated
• Conditions: Upper Gastrointestinal Bleeding; Liver Cirrhoses; Esophageal Varices; Bleeding Esophageal Varices
• Intervention / Treatment: Drug: Octreotide

Detailed Description

In cirrhotic patients with bleeding esophageal varices, standard of care therapy includes administration of octreotide infusion over 72-hours and endoscopic banding of esophageal varices.

Octreotide acts to reduce the pressure in the blood vessels surrounding the liver, decreasing the propensity of bleeding from esophageal varices. The recommended duration of octreotide therapy is based largely on expert opinion, however a 72-hour duration of treatment is likely to be unnecessary and may inappropriately increase hospital and medical costs.

This study aims to determine the safety of 24-hours of octreotide infusion in patients with bleeding esophageal varices.

• Study Type: Interventional
• Enrollment (Actual): 34
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Florida
    • Jacksonville, Florida, United States, 32209
      • University of Florida Health
  • Illinois
    • Chicago, Illinois, United States, 60607
      • University of Illinois at Chicago
  • Ohio
    • Columbus, Ohio, United States, 43210
      • The Ohio State University
  • Oregon
    • Portland, Oregon, United States, 97239
      • Oregon Health & Science University
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Medical University of South Carolina
  • Texas
    • Austin, Texas, United States, 78712
      • The University of Texas at Austin
    • El Paso, Texas, United States, 79905
      • Texas Tech University Health Sciences Center
    • Houston, Texas, United States, 78234
      • Brooke Army Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 24-hour octreotide infusion; Patients will receive octreotide infusion over 24 hours	Drug: Octreotide; Octreotide infusion for 24-hours in patients with bleeding esophageal varices.
Active Comparator: 72-hour octreotide infusion; Patients will receive octreotide infusion over 72 hours	Drug: Octreotide; Octreotide infusion for 24-hours in patients with bleeding esophageal varices.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Medical University of South Carolina
• Collaborators: Ohio State University; University of Texas Southwestern Medical Center; University of Florida Health
• Investigators: Principal Investigator: Don Rockey, M.D, Medical University of South Carolina

Publications and helpful links

General Publications

• Allam J, De Melo S, Feagins LA, Agrawal D, Malespin M, Shuja A, Lara LF, Rockey DC. Comparison of 24 vs 72-hr octreotide infusion in acute esophageal variceal hemorrhage - A multi-center, randomized clinical trial. Am J Med Sci. 2025 Jan;369(1):71-76. doi: 10.1016/j.amjms.2024.08.027. Epub 2024 Sep 4.

Study record dates

Study Major Dates

• Study Start (Actual): September 19, 2018
• Primary Completion (Actual): December 1, 2024
• Study Completion (Actual): December 1, 2024

Study Registration Dates

• First Submitted: July 31, 2018
• First Submitted That Met QC Criteria: August 8, 2018
• First Posted (Actual): August 10, 2018

Study Record Updates

• Last Update Posted (Actual): November 20, 2025
• Last Update Submitted That Met QC Criteria: November 6, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Digestive System Diseases; Gastrointestinal Diseases; Hemorrhage; Liver Diseases; Esophageal Diseases; Hypertension, Portal; Pathological Conditions, Signs and Symptoms; Gastrointestinal Hemorrhage; Esophageal and Gastric Varices; Peptides; Amino Acids, Peptides, and Proteins; Polycyclic Compounds; Macrocyclic Compounds; Peptides, Cyclic; Octreotide
• Other Study ID Numbers: Pro00027015

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes