Ignite Creation Date:
2024-05-06 @ 8:53 AM
Last Modification Date:
2024-10-26 @ 12:06 PM
Study NCT ID:
NCT02848612
Status:
COMPLETED
Last Update Posted:
2018-10-12
First Post:
2016-07-26
Brief Title:
Evaluation of the Amiens University Hospital Neuroradiology Anticoagulation Protocol
Sponsor:
Centre Hospitalier Universitaire Amiens
Organization:
Centre Hospitalier Universitaire Amiens
Study Overview
Official Title:
Evaluation of the Amiens University Hospital Neuroradiology Anticoagulation Protocol
Status:
COMPLETED
Status Verified Date:
2018-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ANTICONEURORAD
Brief Summary:
To prevent thromboembolic complications the embolization procedure is performed under prophylactic unfractionated heparin the efficacy of which is monitored by point-of- care testing according to international guidelines However these guidelines are based on limited scientific evidence and the ideal level of anticoagulation required has not been precisely defined Furthermore the correlation between the point-of- care tests used at Amiens University Hospital and the reference methods used in the laboratory varies considerably according to the available literature
Detailed Description:
Since the beginning of the 2000s the reference treatment for the management of aneurysmal subarachnoid haemorrhage consists of interventional neuroradiology with coil embolization of the aneurysm Although ensuring a better neurological prognosis than neurosurgical clipping interventional neuroradiology exposes the patient to various risks thromboembolic complications during or after embolization and re-rupture of the aneurysm during embolization To prevent thromboembolic complications the embolization procedure is performed under prophylactic unfractionated heparin the efficacy of which is monitored by point-of- care testing according to international guidelines However these guidelines are based on limited scientific evidence and the ideal level of anticoagulation required has not been precisely defined Furthermore the correlation between the point-of- care tests used at Amiens University Hospital and the reference methods used in the laboratory varies considerably according to the available literature
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