Overview

Safety Study of Octreotide Injection to Prevent GI Bleeding in Patients With Left Ventricular Assist Device (LVAD)

Status:
Completed
Trial end date:
2014-10-01
Target enrollment:
0
Participant gender:
All
Summary
The investigators hypothesize that octreotide LAR (Long Acting Release) safely decreases GI bleeding in patients with a left ventricular assist device (LVAD). Patients undergoing implantation of non-pulsatile, continuous-flow LVAD have a higher incidence of gastrointestinal bleeding. This is a significantly associated morbidity and can threaten a patient's life as well as their ability to undergo eventual heart transplantation secondary to both general health/strength and the potential development of antibodies to blood products that would make future transfusions and transplantations more difficult. If this research finds that use of octreotide LAR can decrease the incidence of gastrointestinal bleeding in this patient population, it will revolutionize the manner in which these patients are managed. The finding of reduced GI bleeding would allow the patient to have less exposure to blood products, reduce hospitalizations, and ensure that subsequent transplant planning not be delayed. This would not only be of great benefit to the patient, but would significantly decrease health-care costs through preventive measures. The goal of this project is to study whether the regular administration of monthly octreotide LAR is safe and if it will decrease the incidence of gastrointestinal bleeding in patients undergoing implantation of non-pulsatile, continuous flow left ventricular assist devices (LVAD).
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Virginia Commonwealth University
Collaborators:
Novartis
Thoratec Corporation
Treatments:
Octreotide
Criteria
Inclusion Criteria:

- LVAD insertion as bridge to transplant or destination

- 18 years of age or older

Exclusion Criteria:

- Poorly controlled diabetes, A1C greater than 8%

- Poorly controlled hypothyroidism, TSH > upper limit of normal (5.5)

- End Stage Renal Disease (ESRD) requiring dialysis

- Cirrhosis

- Anemia (Hgb < 8)

- Acromegaly

- Hx of chronic diarrhea - as determined by history of loose stool lasting longer than
2-4 weeks

- Pregnancy or breastfeeding

- Inability to provide informed consent

- Incarceration or otherwise a ward of the state

- Non-English speaking