Decompressive Craniectomy In Malignant Middle Cerebral Artery Infarcts

Phase 3TerminatedNCT00190203

Assistance Publique - Hôpitaux de Paris60 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Malignant Middle Cerebral Artery Infarction

Interventions

Decompressive hemicraniectomy and duraplastyPROCEDURE

Decompressive hemicraniectomy and duraplasty

hemicraniectomyPROCEDURE

hemicraniectomy

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 Years

Medical Language ↔ Plain English

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.

Locations (1)

Hôpital Lariboisière, Assistance Publique - Hôpitaux de Paris

Paris, France

Outcomes

Primary Outcomes

Primary endpoint: Functional outcome at 6 months

Time frame: at 6 months

Secondary Outcomes

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

Data from ClinicalTrials.gov

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