Clinical Trial: Decompressive Craniectomy In Malignant Middle Cerebral Artery Infarcts

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: Decompressive Craniectomy In Malignant Middle Cerebral Artery Infarcts : A Sequential Design, Multicenter, Randomized, Controlled Trial

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 Summary:

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.


Sponsor: Assistance Publique - Hôpitaux de Paris

Current Primary Outcome: Primary endpoint: Functional outcome at 6 months [ Time Frame: at 6 months ]

Original Primary Outcome: Primary endpoint: Functional outcome at 6 months

Current Secondary Outcome:

  • Secondary endpoints: [ Time Frame: during the study ]
  • Mortality [ Time Frame: during the study ]
  • Functional outcome at 9 and 12 months (mRS, NIHSS, Barthel-index) after stroke [ Time Frame: at 9 and 12 months and after stroke ]
  • Quality of life at 6 and 12 months (SIS) [ Time Frame: at 6 and 12 months ]
  • Complications related to surgery [ Time Frame: during the study ]
  • Infarct size at day 5-14 and week 12 and 48 [ Time Frame: at day 5-14 and week 12 and 48 ]
  • Brainstem lesions on T2* after day 5-14 and week 12 and 48 [ Time Frame: after day 5-14 and week 12 and 48 ]


Original Secondary Outcome:

  • Secondary endpoints:
  • 1. Mortality
  • 2. Functional outcome at 9 and 12 months (mRS, NIHSS, Barthel-index) after stroke
  • 3. Quality of life at 6 and 12 months (SIS)
  • 4. Complications related to surgery
  • 5. Infarct size at day 5-14 and week 12 and 48
  • 6. Brainstem lesions on T2* after day 5-14 and week 12 and 48


Information By: Assistance Publique - Hôpitaux de Paris

Dates:
Date Received: September 13, 2005
Date Started: December 2001
Date Completion:
Last Updated: January 16, 2008
Last Verified: September 2007