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

Sponsor

Medical University of South Carolina (Other)

Overall Status

Recruiting

CT.gov ID

NCT03624517

Collaborator

Ohio State University (Other), University of Texas Southwestern Medical Center (Other), University of Florida Health (Other)

160

Enrollment

Locations

Arms

86.4

Anticipated Duration (Months)

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Esophageal Varices Liver Cirrhoses Bleeding Esophageal Varices Upper Gastrointestinal Bleeding	Drug: Octreotide	Phase 4

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 Design

Study Type:

Interventional

Anticipated Enrollment :

160 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Sep 19, 2018

Anticipated Primary Completion Date :

Dec 1, 2024

Anticipated Study Completion Date :

Dec 1, 2025

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Esophageal varices rebleed within 72-hours after control of initial bleed [72 hours]
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 [7 days and 30 days]
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 [7 days and 30 days]
Survival at 7 days and 30 days.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Florida Health	Jacksonville	Florida	United States	32209
2	University of Illinois at Chicago	Chicago	Illinois	United States	60607
3	The Ohio state University	Columbus	Ohio	United States	43210
4	Oregon Health & Science University	Portland	Oregon	United States	97239
5	Medical University of South Carolina	Charleston	South Carolina	United States	29425
6	The University of Texas at Austin	Austin	Texas	United States	78712
7	Texas Tech University Health Sciences Center	El Paso	Texas	United States	79905
8	Brooke Army Medical Center	Houston	Texas	United States	78234