Back to resultsDecompressive Craniectomy In Malignant Middle Cerebral Artery Infarcts (DECIMAL)
Primary Purpose
Malignant Middle Cerebral Artery Infarction
Status
Terminated
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
Decompressive hemicraniectomy and duraplasty
hemicraniectomy
Sponsored by
About this trial
This is an interventional treatment trial for Malignant Middle Cerebral Artery Infarction focused on measuring Malignant middle cerebral artery infarction, Decompressive surgery, Hemicraniectomy, Brain edema
Eligibility 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.
Sites / Locations
- Hôpital Lariboisière, Assistance Publique - Hôpitaux de Paris
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
A
Arm Description
HEMICRANIECTOMY
Outcomes
Primary Outcome Measures
Primary endpoint: Functional outcome at 6 months
Secondary Outcome Measures
Secondary endpoints:
Mortality
Functional outcome at 9 and 12 months (mRS, NIHSS, Barthel-index) after stroke
Quality of life at 6 and 12 months (SIS)
Complications related to surgery
Infarct size at day 5-14 and week 12 and 48
Brainstem lesions on T2* after day 5-14 and week 12 and 48
Full Information
NCT ID
NCT00190203
First Posted
September 13, 2005
Last Updated
January 16, 2008
Sponsor
Assistance Publique - Hôpitaux de Paris
1. Study Identification
Unique Protocol Identification Number
NCT00190203
Brief Title
Decompressive Craniectomy In Malignant Middle Cerebral Artery Infarcts
Acronym
DECIMAL
Official Title
Decompressive Craniectomy In Malignant Middle Cerebral Artery Infarcts : A Sequential Design, Multicenter, Randomized, Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
September 2007
Overall Recruitment Status
Terminated
Why Stopped
the study is publiched
Study Start Date
December 2001 (undefined)
Primary Completion Date
May 2006 (Actual)
Study Completion Date
May 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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 management.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malignant Middle Cerebral Artery Infarction
Keywords
Malignant middle cerebral artery infarction, Decompressive surgery, Hemicraniectomy, Brain edema
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Experimental
Arm Description
HEMICRANIECTOMY
Intervention Type
Procedure
Intervention Name(s)
Decompressive hemicraniectomy and duraplasty
Intervention Description
Decompressive hemicraniectomy and duraplasty
Intervention Type
Procedure
Intervention Name(s)
hemicraniectomy
Intervention Description
hemicraniectomy
Primary Outcome Measure Information:
Title
Primary endpoint: Functional outcome at 6 months
Time Frame
at 6 months
Secondary Outcome Measure Information:
Title
Secondary endpoints:
Time Frame
during the study
Title
Mortality
Time Frame
during the study
Title
Functional outcome at 9 and 12 months (mRS, NIHSS, Barthel-index) after stroke
Time Frame
at 9 and 12 months and after stroke
Title
Quality of life at 6 and 12 months (SIS)
Time Frame
at 6 and 12 months
Title
Complications related to surgery
Time Frame
during the study
Title
Infarct size at day 5-14 and week 12 and 48
Time Frame
at day 5-14 and week 12 and 48
Title
Brainstem lesions on T2* after day 5-14 and week 12 and 48
Time Frame
after day 5-14 and week 12 and 48
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Katayoun VAHEDI, MD
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôpital Lariboisière, Assistance Publique - Hôpitaux de Paris
City
Paris
ZIP/Postal Code
75010
Country
France
12. IPD Sharing Statement
Citations:
PubMed Identifier
17303527
Citation
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. doi: 10.1016/S1474-4422(07)70036-4.
Results Reference
result
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Decompressive Craniectomy In Malignant Middle Cerebral Artery Infarcts
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