Decompressive Craniectomy In Malignant Middle Cerebral Artery Infarcts

Malignant Middle Cerebral Artery Infarction Clinical Trial

— DECIMAL  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00190203
• Other study ID #: P001004
• Secondary ID: AOM00148
• Status: Terminated
• Phase: Phase 3
• First received: September 13, 2005
• Last updated: January 16, 2008
• Start date: December 2001
• Est. completion date: May 2006

Study information

• Verified date: September 2007
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 60
• Est. completion date: May 2006
• Est. primary completion date: May 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Infarction
• Infarction, Middle Cerebral Artery
• Malignant Middle Cerebral Artery Infarction

Intervention

Procedure:
• Decompressive hemicraniectomy and duraplasty
Decompressive hemicraniectomy and duraplasty
• hemicraniectomy
hemicraniectomy

Locations

Country	Name	City	State
France	Hôpital Lariboisière, Assistance Publique - Hôpitaux de Paris	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

References & Publications (1)

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 m — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary endpoint: Functional outcome at 6 months		at 6 months	No
Secondary	Secondary endpoints:		during the study	No
Secondary	Mortality		during the study	No
Secondary	Functional outcome at 9 and 12 months (mRS, NIHSS, Barthel-index) after stroke		at 9 and 12 months and after stroke	Yes
Secondary	Quality of life at 6 and 12 months (SIS)		at 6 and 12 months	Yes
Secondary	Complications related to surgery		during the study	Yes
Secondary	Infarct size at day 5-14 and week 12 and 48		at day 5-14 and week 12 and 48	Yes
Secondary	Brainstem lesions on T2* after day 5-14 and week 12 and 48		after day 5-14 and week 12 and 48	Yes