Ignite Creation Date:
2024-05-06 @ 8:35 AM
Last Modification Date:
2024-10-26 @ 12:02 PM
Study NCT ID:
NCT02777424
Status:
COMPLETED
Last Update Posted:
2024-06-05
First Post:
2016-05-12
Brief Title:
CPP Versus PFC to Correct Coagulation Disorders in Adult Neurosurgical Patients
Sponsor:
Fondation Ophtalmologique Adolphe de Rothschild
Organization:
Fondation Ophtalmologique Adolphe de Rothschild
Study Overview
Official Title:
Prothrombin Complex Concentrate Versus Fresh Frozen Plasma to Correct Coagulation Disorders in Adult Neurosurgical Patients
Status:
COMPLETED
Status Verified Date:
2024-06
Last Known Status:
Recruiting
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:
CLOT-CRANE
Brief Summary:
This prospective randomized multicenter study is performed to determine whether prothrombin complex concentrates confers any benefits over fresh frozen plasma in adult neurological patients with coagulation disorders PT value less than 60
Detailed Description:
The coagulation disorders increase the risk of bleeding and are a risk factor of intracranial hemorrhagic complications in neurosurgical patients They are diagnosed more often in emergency on a PT value less than 60 and so they should be corrected as soon as possible Two therapeutic strategies are proposed by French or international recommendations transfusion of fresh frozen plasma FFP or administration of prothrombin complex concentrates PCC
This prospective randomized multicenter study with blinded assessment of the primary endpoint is performed to determine whether PCC confers any benefits over FFP in the neurological patients with coagulation disorders
This prospective randomized multicenter study with blinded assessment of the primary endpoint is performed to determine whether PCC confers any benefits over FFP in the neurological patients with coagulation disorders
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