Status:
TERMINATED
Decompressive Craniectomy In Malignant Middle Cerebral Artery Infarcts
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Malignant Middle Cerebral Artery Infarction
Eligibility:
All Genders
18-55 years
Phase:
PHASE3
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 man...
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 mea...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
December 1 2001
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2006
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00190203
Start Date
December 1 2001
End Date
May 1 2006
Last Update
January 17 2008
Active Locations (1)
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1
Hôpital Lariboisière, Assistance Publique - Hôpitaux de Paris
Paris, France, 75010