Decompressive Craniectomy In Malignant Middle Cerebral Artery Infarcts (DECIMAL)

Assistance Publique - Hôpitaux de Paris

Status and phase

Terminated

Phase 3

Conditions

Malignant Middle Cerebral Artery Infarction

Treatments

Procedure: hemicraniectomy

Procedure: Decompressive hemicraniectomy and duraplasty

Study type

Interventional

Funder types

Other

Identifiers

NCT00190203

AOM00148

P001004

Details and patient eligibility

About

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.

Full 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.

Enrollment

60 patients

Sex

All

Ages

18 to 55 years old

Volunteers

No Healthy Volunteers

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.