Decompressive Craniectomy In Malignant Middle Cerebral Artery Infarcts (DECIMAL)

January 16, 2008 updated by: Assistance Publique - Hôpitaux de Paris

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France, 75010
        • Hôpital Lariboisière, Assistance Publique - Hôpitaux de Paris

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 53 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: A
HEMICRANIECTOMY
Procedure: Decompressive hemicraniectomy and duraplasty
Decompressive hemicraniectomy and duraplasty
Procedure: hemicraniectomy
hemicraniectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Primary endpoint: Functional outcome at 6 months
Time Frame: at 6 months
at 6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Secondary endpoints:
Time Frame: during the study
during the study
Mortality
Time Frame: during the study
during the study
Functional outcome at 9 and 12 months (mRS, NIHSS, Barthel-index) after stroke
Time Frame: at 9 and 12 months and after stroke
at 9 and 12 months and after stroke
Quality of life at 6 and 12 months (SIS)
Time Frame: at 6 and 12 months
at 6 and 12 months
Complications related to surgery
Time Frame: during the study
during the study
Infarct size at day 5-14 and week 12 and 48
Time Frame: at day 5-14 and week 12 and 48
at day 5-14 and week 12 and 48
Brainstem lesions on T2* after day 5-14 and week 12 and 48
Time Frame: after day 5-14 and week 12 and 48
after day 5-14 and week 12 and 48

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Investigators

  • Principal Investigator: Katayoun VAHEDI, MD, Assistance Publique - Hôpitaux de Paris

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2001

Primary Completion (Actual)

May 1, 2006

Study Completion (Actual)

May 1, 2006

Study Registration Dates

First Submitted

September 13, 2005

First Submitted That Met QC Criteria

September 13, 2005

First Posted (Estimate)

September 19, 2005

Study Record Updates

Last Update Posted (Estimate)

January 17, 2008

Last Update Submitted That Met QC Criteria

January 16, 2008

Last Verified

September 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P001004
  • AOM00148

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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