Clinical trial NCT00190203: Decompressive Craniectomy In Malignant Middle Cerebral Artery Infarcts
Official title: Decompressive Craniectomy In Malignant Middle Cerebral Artery Infarcts : A Sequential Design, Multicenter, Randomized, Controlled Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Malignant Middle Cerebral Artery Infarction
Keywords: Malignant middle cerebral artery infarction
Decompressive surgery
Hemicraniectomy
Brain edema
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2005-09-19
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Primary endpoint: Functional outcome at 6 months
timeFrame: at 6 months
Secondary outcomes:
measure: Secondary endpoints:
timeFrame: during the study
measure: Mortality
timeFrame: during the study
measure: Functional outcome at 9 and 12 months (mRS, NIHSS, Barthel-index) after stroke
timeFrame: at 9 and 12 months and after stroke
measure: Quality of life at 6 and 12 months (SIS)
timeFrame: at 6 and 12 months
measure: Complications related to surgery
timeFrame: during the study
measure: Infarct size at day 5-14 and week 12 and 48
timeFrame: at day 5-14 and week 12 and 48
measure: Brainstem lesions on T2* after day 5-14 and week 12 and 48
timeFrame: after day 5-14 and week 12 and 48
Other outcomes:
Locations:
city: Paris
country: France
facility: Hôpital Lariboisière, Assistance Publique - Hôpitaux de Paris
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Katayoun VAHEDI, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Vahedi K, Hofmeijer J, Juettler E, Vicaut E, George B, Algra A, Amelink GJ, Schmiedeck P, Schwab S, Rothwell PM, Bousser MG, van der Worp HB, Hacke W; DECIMAL, DESTINY, and HAMLET investigators. Early decompressive surgery in malignant infarction of the middle cerebral artery: a pooled analysis of three randomised controlled trials. Lancet Neurol. 2007 Mar;6(3):215-22. doi: 10.1016/S1474-4422(07)70036-4.