Decompressive Craniectomy In Malignant Middle Cerebral Artery Infarcts (DECIMAL)
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Malignant Middle Cerebral Artery Infarction |
Procedure: Decompressive hemicraniectomy and duraplasty Procedure: hemicraniectomy |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Decompressive Craniectomy In Malignant Middle Cerebral Artery Infarcts : A Sequential Design, Multicenter, Randomized, Controlled Trial |
- Primary endpoint: Functional outcome at 6 months [ Time Frame: at 6 months ] [ Designated as safety issue: No ]
- Secondary endpoints: [ Time Frame: during the study ] [ Designated as safety issue: No ]
- Mortality [ Time Frame: during the study ] [ Designated as safety issue: No ]
- Functional outcome at 9 and 12 months (mRS, NIHSS, Barthel-index) after stroke [ Time Frame: at 9 and 12 months and after stroke ] [ Designated as safety issue: Yes ]
- Quality of life at 6 and 12 months (SIS) [ Time Frame: at 6 and 12 months ] [ Designated as safety issue: Yes ]
- Complications related to surgery [ Time Frame: during the study ] [ Designated as safety issue: Yes ]
- Infarct size at day 5-14 and week 12 and 48 [ Time Frame: at day 5-14 and week 12 and 48 ] [ Designated as safety issue: Yes ]
- Brainstem lesions on T2* after day 5-14 and week 12 and 48 [ Time Frame: after day 5-14 and week 12 and 48 ] [ Designated as safety issue: Yes ]
| Enrollment: | 60 |
| Study Start Date: | December 2001 |
| Study Completion Date: | May 2006 |
| Primary Completion Date: | May 2006 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: A
HEMICRANIECTOMY
|
Procedure: Decompressive hemicraniectomy and duraplasty
Decompressive hemicraniectomy and duraplasty
Other Name: Decompressive hemicraniectomy and duraplasty
Procedure: hemicraniectomy
hemicraniectomy
Other Name: hemicraniectomy
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 55 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations| France | |
| Hôpital Lariboisière, Assistance Publique - Hôpitaux de Paris | |
| Paris, France, 75010 | |
| Principal Investigator: | Katayoun VAHEDI, MD | Assistance Publique - Hôpitaux de Paris |
More Information
Publications:
| Responsible Party: | Amel Ouslimany, Department Clinical Research of Departement |
| ClinicalTrials.gov Identifier: | NCT00190203 History of Changes |
| Other Study ID Numbers: | P001004, AOM00148 |
| Study First Received: | September 13, 2005 |
| Last Updated: | January 16, 2008 |
| Health Authority: | France: Ministry of Health |
Keywords provided by Assistance Publique - Hôpitaux de Paris:
|
Malignant middle cerebral artery infarction Decompressive surgery Hemicraniectomy Brain edema |
Additional relevant MeSH terms:
|
Infarction Infarction, Middle Cerebral Artery Ischemia Pathologic Processes Necrosis Cerebral Infarction Brain Infarction Brain Ischemia Cerebrovascular Disorders |
Brain Diseases Central Nervous System Diseases Nervous System Diseases Cerebral Arterial Diseases Intracranial Arterial Diseases Stroke Vascular Diseases Cardiovascular Diseases |
ClinicalTrials.gov processed this record on June 18, 2013