Perioperative Modification of Hemostasis During Ventricular Assist Device Implantation
- Conditions
- End-stage Heart Failure
- Registration Number
- NCT03966313
- Lead Sponsor
- University Hospital, Strasbourg, France
- Brief Summary
Implanting a ventricular assist device (VAD) is a promising therapy for end-stage cardiac failure. However, the implantation of these devices is associated with a high risk of severe hemorrhages and massive blood product transfusion in the first 48 hours following the implantation. The primary purpose of this study is to assess the functionality of the von Willebrand Factor (vWF) which is essential for hemostasis. The hypothesis is that the high shear stress generated by these VAD expose ADAMTS13 cleaving site on the vWF. This result in a loss of high molecular weight vWF and an acquired von Willebrand syndrome.
The secondary purpose of the protocol is to assess platelet function after the implantation of VAD. Indeed, platelet function might be affected shortly after the implantation of the device.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 26
- Age over 18 years old
- Who gave his consent to the study
- With an end-stage heart-failure
- Under surgery for a ventricular assist device implantation
- Scheduled or in emergency
- Preoperative anemia less than 7 g/dL
- Subject under the protection of justice
- Subject under guardianship or curatorship
- Pregnancy
- Breastfeeding
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Von Willebrand Factor activity From Baseline to 48 hours Change of Von Willebrand Factor from Baseline to 48 hours
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Hopitaux Universitaire de Strasbourg
🇫🇷Strasbourg, France