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

January 5, 2024 updated by: Medical University of South Carolina

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

Recruiting

Conditions

Intervention / Treatment

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 (Estimated)

160

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Florida
      • Jacksonville, Florida, United States, 32209
    • Illinois
      • Chicago, Illinois, United States, 60607
        • Recruiting
        • University of Illinois at Chicago
        • Contact:
    • Ohio
      • Columbus, Ohio, United States, 43210
        • Recruiting
        • The Ohio State University
        • Contact:
    • Oregon
      • Portland, Oregon, United States, 97239
        • Not yet recruiting
        • Oregon Health & Science University
        • Contact:
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Recruiting
        • Medical University of South Carolina
        • Contact:
        • Contact:
    • Texas

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Time Frame: 72 hours

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
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
Time Frame: 7 days and 30 days

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
7 days and 30 days
Survival at 7 days and 30 days after control of initial bleed
Time Frame: 7 days and 30 days
Survival at 7 days and 30 days.
7 days and 30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 19, 2018

Primary Completion (Estimated)

December 1, 2024

Study Completion (Estimated)

December 1, 2025

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 (Estimated)

January 8, 2024

Last Update Submitted That Met QC Criteria

January 5, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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