Trial record 3 of 36 for:    "cerebral autosomal recessive arteriopathy with subcortical infarcts and leukoencephalopathy" OR "Cerebral Arterial Diseases"

Decompressive Craniectomy In Malignant Middle Cerebral Artery Infarcts (DECIMAL)

This study has been terminated.
(the study is publiched)
Sponsor:
Information provided by:
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT00190203
First received: September 13, 2005
Last updated: January 16, 2008
Last verified: September 2007
  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

Resource links provided by NLM:


Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • Primary endpoint: Functional outcome at 6 months [ Time Frame: at 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00190203

Locations
France
Hôpital Lariboisière, Assistance Publique - Hôpitaux de Paris
Paris, France, 75010
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
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:
Cerebral Arterial Diseases
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
Intracranial Arterial Diseases
Stroke
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on April 23, 2014