Decompressive Craniectomy In Malignant Middle Cerebral Artery Infarcts

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00190203
• Date of registration: 13/09/2005
• Prospective Registration: No
• Primary sponsor: Assistance Publique - Hôpitaux de Paris
• Public title: Decompressive Craniectomy In Malignant Middle Cerebral Artery Infarcts DECIMAL
• Scientific title: Decompressive Craniectomy In Malignant Middle Cerebral Artery Infarcts : A Sequential Design, Multicenter, Randomized, Controlled Trial
• Date of first enrolment: December 2001
• Target sample size: 60
• Recruitment status: Terminated
• URL: http://clinicaltrials.gov/show/NCT00190203
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 3

Countries of recruitment

France

Contacts

• Name: Katayoun VAHEDI, MD
• Affiliation: Assistance Publique - Hôpitaux de Paris

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: 55 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Malignant Middle Cerebral Artery Infarction

Intervention(s)

Procedure: Decompressive hemicraniectomy and duraplasty

Procedure: hemicraniectomy

Primary Outcome(s)

Primary endpoint: Functional outcome at 6 months [Time Frame: at 6 months]

Secondary Outcome(s)

Brainstem lesions on T2* after day 5-14 and week 12 and 48 [Time Frame: after day 5-14 and week 12 and 48]

Complications related to surgery [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]

Mortality [Time Frame: during the study]

Quality of life at 6 and 12 months (SIS) [Time Frame: at 6 and 12 months]

Secondary endpoints: [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]

Secondary ID(s)

P001004

AOM00148

Source(s) of Monetary Support

Please refer to primary and secondary sponsors