Characterization of the Plasma Proteome Following Left Ventricular Assist Device Implantation

Completed

• Conditions: Ventricular Dysfunction, Left

• 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

Study Timeline

• Study Start: 2014-10
• Study First Submitted: 2015-04-17
• Study First Submitted QC: 2015-04-23
• Study First Posted: 2015-04-29
• Primary Completion: 2017-01
• Study Completion: 2017-01
• Status Verified: 2017-07
• Last Update Submitted: 2017-07-14
• Last Update Posted: 2017-07-17

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

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Quantitative differences in plasma protein abundance	Days 7, 14, 30, 60, 90, and 180 post-LVAD implantation

Trial Locations

Locations (1)

University of Colorado Anschutz Medical Campus; 🇺🇸 Aurora, Colorado, United States