Ignite Creation Date:
2024-05-06 @ 1:13 PM
Last Modification Date:
2024-10-26 @ 1:11 PM
Study NCT ID:
NCT03966313
Status:
TERMINATED
Last Update Posted:
2020-04-22
First Post:
2019-05-17
Brief Title:
Perioperative Modification of Hemostasis During Ventricular Assist Device Implantation
Sponsor:
University Hospital Strasbourg France
Organization:
University Hospital Strasbourg France
Study Overview
Official Title:
Perioperative Modification of Hemostasis During Ventricular Assist Device Implantation
Status:
TERMINATED
Status Verified Date:
2024-10
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Due to inclusion difficulties following the evolution of surgical indications which were clearly restricted making patient inclusion too complex
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HemostVAD
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
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:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None