Ignite Creation Date:
2024-05-05 @ 11:57 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00190203
Status:
TERMINATED
Last Update Posted:
2008-01-17
First Post:
2005-09-13
Brief Title:
Decompressive Craniectomy In Malignant Middle Cerebral Artery Infarcts
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Assistance Publique - Hôpitaux de Paris
Study Overview
Official Title:
Decompressive Craniectomy In Malignant Middle Cerebral Artery Infarcts A Sequential Design Multicenter Randomized Controlled Trial
Status:
TERMINATED
Status Verified Date:
2007-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
the study is publiched
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DECIMAL
Brief Summary:
The purpose of this study is to determine if patients with malignant middle cerebral artery infarction have a better clinical outcome after early decompressive surgery compared to standard medical management
Detailed Description:
The Decompressive Craniectomy In MALignant middle cerebral artery infarction DECIMAL trial is a prospective multicenter randomized open single blind for the evaluation of the primary outcome measure controlled study of the efficacy of decompressive craniectomy plus the standard medical therapy as compared with the standard medical therapy alone in patients with a malignant middle cerebral artery infarction The study protocol is approved by a regional ethic committee CCPPRB Hospital SAINT LOUIS PARIS The study is conducted in 13 stroke centers in France and is funded by the French Ministry of Health and the ASSISTANCE PUBLIQUE- HOPITAUX DE PARIS An independent Data Safety Monitoring Board DSMB monitors the safety progress and ethics of the trial
The aim of the trial is to determine if patients with malignant middle cerebral artery infarction have a better clinical outcome after early decompressive surgery compared to standard medical therapy alone
Secondary objectives are to determine clinical or MRI based prognostic factors of better outcome after decompressive surgery
The aim of the trial is to determine if patients with malignant middle cerebral artery infarction have a better clinical outcome after early decompressive surgery compared to standard medical therapy alone
Secondary objectives are to determine clinical or MRI based prognostic factors of better outcome after decompressive surgery
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 |
|---|---|---|---|
| AOM00148 | None | None | None |