Characterization of the Plasma Proteome Following Left Ventricular Assist Device Implantation
Completed
- Conditions
- Ventricular Dysfunction, Left
- Interventions
- Device: LVAD
- Registration Number
- NCT02428894
- Lead Sponsor
- University of Colorado, Denver
- Brief Summary
The purpose of this study is to characterize changes in the plasma proteome over time following left ventricular assist device (LVAD) implantation.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 20
Inclusion Criteria
- Planned HeartMate II LVAD implantation
- Planned warfarin (goal INR, 2.0-3.0) and low-dose aspirin therapy post-LVAD placement
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Exclusion Criteria
- Prior history of mechanical circulatory support;
- Body weight < 110 lbs;
- Pre-existing hemolytic, bleeding, or immunologic disorders prior to LVAD implantation;
- Severe aortic stenosis;
- Renal failure requiring dialysis;
- Hepatic dysfunction resulting in severe coagulopathies;
- Recent serious infection;
- Current need for prolonged ventilatory support;
- Prior organ transplantation;
- Blood transfusion within 14 days of the first planned study blood draw;
- Concomitant immunosuppressant or chemotherapeutic agents;
- Pregnant women;
- Decisionally challenged or prisoners;
- Unwilling to provide written informed consent
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Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description LVAD recipients LVAD -
- Primary Outcome Measures
Name Time Method Quantitative differences in plasma protein abundance Days 7, 14, 30, 60, 90, and 180 post-LVAD implantation
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
University of Colorado Anschutz Medical Campus
🇺🇸Aurora, Colorado, United States