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

Completed · Phase 1

Conditions studied: Gastrointestinal Bleeding

In brief

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).

Key facts

Study ID

NCT01707225

Run by

Virginia Commonwealth University

People needed

10

Starts

2013-02-01

Expected to finish

2014-10-01

Last updated by the study team

2017-02-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• LVAD insertion as bridge to transplant or destination
• 18 years of age or older

You may not qualify if…

• 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

Where it is running

• Virginia Commonwealth University Health System — Richmond, Virginia, United States

Full record on ClinicalTrials.gov

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