Ignite Creation Date:
2024-05-06 @ 7:09 AM
Last Modification Date:
2024-10-26 @ 11:45 AM
Study NCT ID:
NCT02488525
Status:
TERMINATED
Last Update Posted:
2019-07-11
First Post:
2015-07-01
Brief Title:
Prevention of Hemorrhage After Implantation of Mechanical Circulatory Support
Sponsor:
University Hospital Lille
Organization:
University Hospital Lille
Study Overview
Official Title:
Prevention of Hemorrhage After Implantation of Mechanical Circulatory Support
Status:
TERMINATED
Status Verified Date:
2019-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
deficient inclusion
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PHAM
Brief Summary:
Main objective of the study is to demonstrate that a prophylactic treatment with VWF factor concentrate after implantation of continuous-flow left ventricular assist device CF-LVAD reduces the frequency of clinically significant bleeding within 3 months after implantation in comparison to the usual care Adult patients with functional defects of VWF measured after implantation of continuous LVAD are randomly assigned to prophylactic treatment
Detailed Description:
This time point was chosen because the bleeding events are maximal within the first 3 months after implantation
Adult patients 18 years who need a CF-LVAD due to advanced heart failure
Functional To determine the potential indication of Wilfactin in the field of CF-LVAD and avoid widespread use and to establish evidence-based recommendation To improve the knowledge of the role of VWF concentrate in bleeding and angiogenesis after CF-LVAD implantation and to provide some results about mechanism involved angiogenesis or hemostasis
Adult patients 18 years who need a CF-LVAD due to advanced heart failure
Functional To determine the potential indication of Wilfactin in the field of CF-LVAD and avoid widespread use and to establish evidence-based recommendation To improve the knowledge of the role of VWF concentrate in bleeding and angiogenesis after CF-LVAD implantation and to provide some results about mechanism involved angiogenesis or hemostasis
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2015-001231-20 | EUDRACT_NUMBER | None | None |
| PHRC-14-0469 | OTHER | Ministry of health France | None |