Malignant Middle Cerebral Artery Infarction Clinical Trial
Official title:
Decompressive Craniectomy In Malignant Middle Cerebral Artery Infarcts : A Sequential Design, Multicenter, Randomized, Controlled Trial
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.
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.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment