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

September 13, 2005
January 16, 2008
December 2001
May 2006   (final data collection date for primary outcome measure)
Primary endpoint: Functional outcome at 6 months [ Time Frame: at 6 months ] [ Designated as safety issue: No ]
Primary endpoint: Functional outcome at 6 months
Complete list of historical versions of study NCT00190203 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Secondary endpoints:
  • 1. Mortality
  • 2. Functional outcome at 9 and 12 months (mRS, NIHSS, Barthel-index) after stroke
  • 3. Quality of life at 6 and 12 months (SIS)
  • 4. Complications related to surgery
  • 5. Infarct size at day 5-14 and week 12 and 48
  • 6. Brainstem lesions on T2* after day 5-14 and week 12 and 48
Not Provided
Not Provided
 
Decompressive Craniectomy In Malignant Middle Cerebral Artery Infarcts
Decompressive Craniectomy In Malignant Middle Cerebral Artery Infarcts : A Sequential Design, Multicenter, Randomized, Controlled Trial

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Malignant Middle Cerebral Artery Infarction
  • Procedure: Decompressive hemicraniectomy and duraplasty
    Decompressive hemicraniectomy and duraplasty
    Other Name: Decompressive hemicraniectomy and duraplasty
  • Procedure: hemicraniectomy
    hemicraniectomy
    Other Name: hemicraniectomy
Experimental: A
HEMICRANIECTOMY
Interventions:
  • Procedure: Decompressive hemicraniectomy and duraplasty
  • Procedure: hemicraniectomy
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 middle cerebral artery: a pooled analysis of three randomised controlled trials. Lancet Neurol. 2007 Mar;6(3):215-22.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
60
May 2006
May 2006   (final data collection date for primary outcome measure)

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.
Both
18 Years to 55 Years
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00190203
P001004, AOM00148
Yes
Amel Ouslimany, Department Clinical Research of Departement
Assistance Publique - Hôpitaux de Paris
Not Provided
Principal Investigator: Katayoun VAHEDI, MD Assistance Publique - Hôpitaux de Paris
Assistance Publique - Hôpitaux de Paris
September 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP