Onset and Offset of Von Willebrand Factor Multimemirization Defects in Cardiovascular Disease: the Case of the Molecular Sensor of Blood Flow
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 500
- Locations
- 2
- Primary Endpoint
- Von Willebrand factor (VWF) multimer defects
Study Overview
Brief Summary
The WITAVI study was designed to explore the kinetic and associated outcome of Von Willebrand Factor-multimerizaton defects associated with devices in cardiovascular diseases.
Detailed Description
This study was designed to understand the Von Willebrand Factor (VWF) abnormalities observed in association with implantation of different devices in cardiovascular diseases (percutaneous valve replacement and circulatory support devices).
The main objective of the study was to describe the time-course of VWF abnormalities onset/offset during implantation of devices in cardiovascular diseases.
Adult patients > 18 years who need a CF-LVAD or trans-aortic valve implantation are included in this cohort; Blood samples are obtained just before procedures
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Adult patients > 18 years who need a mechanical circulatory support due to advanced heart failure or undergoing trans-aortic-valve-replacement to treat aortic stenosis.
- •Informed consent of the patient or support person in case of disability at baseline (patient intubated and ventilated)
Exclusion Criteria
- •Patient with a known severe bleeding disorder
- •Patient refusal or environment
- •Minor patients
- •Pregnant women
Outcomes
Primary Outcomes
Von Willebrand factor (VWF) multimer defects
Time Frame: 180 minutes after device implantation
VWF multimeric analysis is performed by electrophoresis. The results of HMW-multimers are expressed as the relative amount of the largest multimers (mer\>15) of the sample compared with those of the normal pooled plasma (NPP standard human plasma Siemens healthcare diagnostics, Marburg, Germany, coefficient of variation=11%) present on each gel. 4-6 With this method the HMW-multimer ratio is defined as the HMW-multimers (\>15-mer) in patient plasma sample divided by HMW-multimers in normal pool plasma, the HMW-multimer ratio of normal pooled plasma is 1 (by definition) and an HMW-multimer defect is defined as a reduced HMW-multimer-ratio (\<1).
Secondary Outcomes
- platelet function analyser- ADP (PFA-ADP) closure time(5, 15,30, 60 minutes; day 1 , day 7 after device implantation)