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

PHASE1CompletedINTERVENTIONAL
Enrollment

10

Participants

Timeline

Start Date

February 28, 2013

Primary Completion Date

October 31, 2014

Study Completion Date

October 31, 2014

Conditions
Gastrointestinal Bleeding
Interventions
DRUG

Octreotide LAR Depot

The subject will be seen in clinic every 4 weeks (+/- 4 days) through week 24. During weeks 25-36 the subject will receive a telephone call every 4 weeks +/- 4 days, from the research nurse to assess for changes occurring after the study drug was stopped. Subjects will receive a physical exam and interview at each visit to assess for any sign of GI bleeding at home as per standard protocol for HeartMate II patients and for potential drug related side effects. Labs collected for research will include monthly basic metabolic panel (BMP), complete blood count (CBC), fructosamine and quarterly HGbA1C , VEGF, vWF, vWF activity assay, thyroid stimulating hormone (TSH), platelet function test and fibrinogen. Subjects will receive their monthly injection while in clinic for their every 4 weeks appointment. The subjects will be followed and data will be collected for 36 weeks, or for as long as they are enrolled in the study.

Trial Locations (1)

23298

Virginia Commonwealth University Health System, Richmond

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Thoratec Corporation

INDUSTRY

collaborator

Novartis

INDUSTRY

lead

Virginia Commonwealth University

OTHER

NCT01707225 - Safety Study of Octreotide Injection to Prevent GI Bleeding in Patients With Left Ventricular Assist Device (LVAD) | Biotech Hunter | Biotech Hunter