NCT00190203

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Dec 2001

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2001

Completed
3.8 years until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 19, 2005

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2006

Completed
Last Updated

January 17, 2008

Status Verified

September 1, 2007

Enrollment Period

4.4 years

First QC Date

September 13, 2005

Last Update Submit

January 16, 2008

Conditions

Malignant Middle Cerebral Artery Infarction

Keywords

Malignant middle cerebral artery infarctionDecompressive surgeryHemicraniectomyBrain edema

Outcome Measures

Primary Outcomes (1)

  • Primary endpoint: Functional outcome at 6 months

    at 6 months

Secondary Outcomes (7)

  • Secondary endpoints:

    during the study

  • Mortality

    during the study

  • Functional outcome at 9 and 12 months (mRS, NIHSS, Barthel-index) after stroke

    at 9 and 12 months and after stroke

  • Quality of life at 6 and 12 months (SIS)

    at 6 and 12 months

  • Complications related to surgery

    during the study

  • +2 more secondary outcomes

Study Arms (1)

A

EXPERIMENTAL

HEMICRANIECTOMY

Procedure: Decompressive hemicraniectomy and duraplastyProcedure: hemicraniectomy

Interventions

Decompressive hemicraniectomy and duraplastyPROCEDURE

Decompressive hemicraniectomy and duraplasty

A
hemicraniectomyPROCEDURE

hemicraniectomy

A

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Clinical and CT scan signs of complete infarction of the middle cerebral artery
  • DWI infarct volume \> 145 cm3

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital Lariboisière, Assistance Publique - Hôpitaux de Paris

Paris, 75010, France

Location

Related Publications (1)

  • 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.

    PMID: 17303527RESULT

MeSH Terms

Conditions

Brain Edema

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Katayoun VAHEDI, MD

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 19, 2005

Study Start

December 1, 2001

Primary Completion

May 1, 2006

Study Completion

May 1, 2006

Last Updated

January 17, 2008

Record last verified: 2007-09

Locations

FR(1)