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

Primary Purpose

Esophageal Varices, Liver Cirrhoses, Bleeding Esophageal Varices

Status
Recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Octreotide
Sponsored by
Medical University of South Carolina
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Esophageal Varices

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Florida HealthRecruiting
  • University of Illinois at ChicagoRecruiting
  • The Ohio state UniversityRecruiting
  • Oregon Health & Science University
  • Medical University of South CarolinaRecruiting
  • The University of Texas at AustinRecruiting
  • Texas Tech University Health Sciences CenterRecruiting
  • Brooke Army Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

24-hour octreotide infusion

72-hour octreotide infusion

Arm Description

Patients will receive octreotide infusion over 24 hours

Patients will receive octreotide infusion over 72 hours

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
July 31, 2018
Last Updated
January 10, 2023
Sponsor
Medical University of South Carolina
Collaborators
Ohio State University, University of Texas Southwestern Medical Center, University of Florida Health
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1. Study Identification

Unique Protocol Identification Number
NCT03624517
Brief Title
Comparison of 24-hours Versus 72-hours of Octreotide Infusion in Preventing Early Rebleed From Esophageal Varices
Acronym
LOVARB
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 19, 2018 (Actual)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
December 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medical University of South Carolina
Collaborators
Ohio State University, University of Texas Southwestern Medical Center, University of Florida Health

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Esophageal Varices, Liver Cirrhoses, Bleeding Esophageal Varices, Upper Gastrointestinal Bleeding

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
160 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
24-hour octreotide infusion
Arm Type
Experimental
Arm Description
Patients will receive octreotide infusion over 24 hours
Arm Title
72-hour octreotide infusion
Arm Type
Active Comparator
Arm Description
Patients will receive octreotide infusion over 72 hours
Intervention Type
Drug
Intervention Name(s)
Octreotide
Intervention Description
Octreotide infusion for 24-hours in patients with bleeding esophageal varices.
Primary Outcome Measure Information:
Title
Esophageal varices rebleed within 72-hours after control of initial bleed
Description
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
Time Frame
72 hours
Secondary Outcome Measure Information:
Title
Esophageal varices rebleed at 7 days and 30 days after control of initial bleed
Description
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
Time Frame
7 days and 30 days
Title
Survival at 7 days and 30 days after control of initial bleed
Description
Survival at 7 days and 30 days.
Time Frame
7 days and 30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adult males and females who are 18 years of age or older. Evidence or suspicion of upper gastrointestinal bleed (GIB) Patient with known or suspected cirrhosis Upper GIB secondary to bleeding esophageal varices as show by esophageal endoscopy, requiring endoscopic band ligation (EBL) at presentation 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: Known upper gastrointestinal malignancy Bleeding from gastric varices, with or without esophageal varices Use of any other endoscopic method to stop GI bleeding beyond endoscopic band ligation Variceal bleeding in the last 90 days History of transjugular, intrahepatic, portosystemic shunt (TIPS) or vascular decompression surgery Pregnant females Incarcerated individuals Myocardial infarct, cerebrovascular accident, sepsis, respiratory failure, or severe intercurrent illness within the previous 6 weeks Non-cirrhotic portal hypertension causing esophageal varices Known or suspected allergy to octreotide
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kareem Marrache, M.D
Phone
8438767233
Email
marrache@musc.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Sara Hatoum, M.D
Phone
8437920650
Email
hatoum@musc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Don Rockey, M.D
Organizational Affiliation
Medical University of South Carolina
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Florida Health
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32209
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Miguel Malespin, M.D
Email
miguel.malespin@jax.ufl.edu
Facility Name
University of Illinois at Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60607
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Asim Shuja, MD
Email
ashuja@uic.edu
Facility Name
The Ohio state University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Luis Lara, M.D
Phone
614-293-8000
Email
Luis.Lara@osumc.edu
Facility Name
Oregon Health & Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Silvio De Melo
Email
demelo@ohsu.edu
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Don Rockey, M.D
Phone
843-792-2914
Email
rockey@musc.edu
First Name & Middle Initial & Last Name & Degree
Kareemn Marrache, M.D
Email
marrache@musc.edu
Facility Name
The University of Texas at Austin
City
Austin
State/Province
Texas
ZIP/Postal Code
78712
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Linda A Feagins, MD
Email
linda.feagins@austin.utexas.edu
First Name & Middle Initial & Last Name & Degree
Deepak Agrawal, MD
Phone
5124955618
Email
deepak.agrawal@austin.utexas.edu
Facility Name
Texas Tech University Health Sciences Center
City
El Paso
State/Province
Texas
ZIP/Postal Code
79905
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Antonio Mendoza-Ladd, MD
Email
Antonio.Mendoza-Ladd@ttuhsc.edu
First Name & Middle Initial & Last Name & Degree
Nancy Casner
Email
Nancy.Casner@ttuhsc.edu
Facility Name
Brooke Army Medical Center
City
Houston
State/Province
Texas
ZIP/Postal Code
78234
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jerry Edelson, MD
Email
jerry.edelson@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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