Decompressive Craniectomy In Malignant Middle Cerebral Artery Infarcts

NCT ID: NCT00190203

Last Updated: 2008-01-17

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2001-12-31
• Study Completion Date: 2006-05-31

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.

Conditions

Malignant Middle Cerebral Artery Infarction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

A

HEMICRANIECTOMY

Group Type: EXPERIMENTAL

Decompressive hemicraniectomy and duraplasty

Intervention Type: PROCEDURE

Decompressive hemicraniectomy and duraplasty

hemicraniectomy

Intervention Type: PROCEDURE

hemicraniectomy

Interventions

Decompressive hemicraniectomy and duraplasty

Decompressive hemicraniectomy and duraplasty

Intervention Type: PROCEDURE

hemicraniectomy

hemicraniectomy

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Department Clinical Research of Departement

Principal Investigators

Katayoun VAHEDI, MD

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique - Hôpitaux de Paris

Locations

Hôpital Lariboisière, Assistance Publique - Hôpitaux de Paris

Paris, , France

Countries

France

References

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.

Reference Type: RESULT

PMID: 17303527 (View on PubMed)

Other Identifiers

AOM00148

Identifier Type: -

Identifier Source: secondary_id

P001004

Identifier Type: -

Identifier Source: org_study_id