Decompressive Craniectomy In Malignant Middle Cerebral Artery Infarcts

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Malignant Middle Cerebral Artery Infarction

Intervention / Treatment
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* Procedure: Decompressive hemicraniectomy and duraplasty
* Procedure: hemicraniectomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinical and CT scan signs of complete infarction of the middle cerebral artery Onset of symptoms < 30 hours to a possible surgical intervention (< 24 hours for the inclusion and possibility to start treatment/surgery within 6 hours after randomisation) DWI infarct volume > 145 cm3 Exclusion criteria: The patients having a neurological pre existing handicap (score of Rankin sup or equal in 2). Patients having an ischaemia lateral against significant. Patients having a haemorrhagic transformation(conversion) sup in 50 % of the territory of the infarct. Patients having a severe co-morbidity with a reduced life expectation. Patients having a severe cardio-respiratory co-morbidity. Patients having antecedent of DUROPLASTIE with transplant of dura mater or transplant of cornea. Patients having a thrombolyses in 24 last hours. Patients having a severe coagulopathies. Patients having one against indication in the general anesthetic. Patients for whom a medical follow-up is not possible. The pregnant women. The patients to whom the surgical operation cannot be realized within 6 hours following the randomisation.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br>HEMICRANIECTOMY | Procedure: Decompressive hemicraniectomy and duraplasty<br>* Decompressive hemicraniectomy and duraplasty<br>Procedure: hemicraniectomy<br>* hemicraniectomy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary endpoint: Functional outcome at 6 months |  | at 6 months | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hemicraniectomy, Malignant middle cerebral artery infarction, Decompressive surgery, Brain edema