Recruitment

Recruitment Status
Recruiting

Inclusion Criteria

Evidence or suspicion of upper gastrointestinal bleed (GIB)
Adult males and females who are 18 years of age or older.
Patient with known or suspected cirrhosis
...
Evidence or suspicion of upper gastrointestinal bleed (GIB)
Adult males and females who are 18 years of age or older.
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

History of transjugular, intrahepatic, portosystemic shunt (TIPS) or vascular decompression surgery
Known or suspected allergy to octreotide
Myocardial infarct, cerebrovascular accident, sepsis, respiratory failure, or severe intercurrent illness within the previous 6 weeks
...
History of transjugular, intrahepatic, portosystemic shunt (TIPS) or vascular decompression surgery
Known or suspected allergy to octreotide
Myocardial infarct, cerebrovascular accident, sepsis, respiratory failure, or severe intercurrent illness within the previous 6 weeks
Non-cirrhotic portal hypertension causing esophageal varices
Known upper gastrointestinal malignancy
Use of any other endoscopic method to stop GI bleeding beyond endoscopic band ligation
Bleeding from gastric varices, with or without esophageal varices
Variceal bleeding in the last 90 days
Incarcerated individuals
Pregnant females

Summary

Conditions
  • Bleeding Esophageal Varices
  • Esophageal Varices
  • Liver Cirrhoses
  • Upper Gastrointestinal Bleeding
Type
Interventional
Phase
Phase 4
Design
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: Single (Outcomes Assessor)
  • Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

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 ...

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.

Inclusion Criteria

Evidence or suspicion of upper gastrointestinal bleed (GIB)
Adult males and females who are 18 years of age or older.
Patient with known or suspected cirrhosis
...
Evidence or suspicion of upper gastrointestinal bleed (GIB)
Adult males and females who are 18 years of age or older.
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

History of transjugular, intrahepatic, portosystemic shunt (TIPS) or vascular decompression surgery
Known or suspected allergy to octreotide
Myocardial infarct, cerebrovascular accident, sepsis, respiratory failure, or severe intercurrent illness within the previous 6 weeks
...
History of transjugular, intrahepatic, portosystemic shunt (TIPS) or vascular decompression surgery
Known or suspected allergy to octreotide
Myocardial infarct, cerebrovascular accident, sepsis, respiratory failure, or severe intercurrent illness within the previous 6 weeks
Non-cirrhotic portal hypertension causing esophageal varices
Known upper gastrointestinal malignancy
Use of any other endoscopic method to stop GI bleeding beyond endoscopic band ligation
Bleeding from gastric varices, with or without esophageal varices
Variceal bleeding in the last 90 days
Incarcerated individuals
Pregnant females

Locations

Jacksonville, Florida, 32209
Austin, Texas, 78712
Charleston, South Carolina, 29425
El Paso, Texas, 79905
Columbus, Ohio, 43210
...
Jacksonville, Florida, 32209
Austin, Texas, 78712
Charleston, South Carolina, 29425
El Paso, Texas, 79905
Columbus, Ohio, 43210
Portland, Oregon, 97239
Chicago, Illinois, 60607
Houston, Texas, 78234

Tracking Information

NCT #
NCT03624517
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
  • Don Rockey, M.D Medical University of South Carolina