Trial document





This trial has been registered retrospectively.
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  DRKS00000624

Trial Description

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Title

DEcompressive Surgery for the Treatment of malignant INfarction of the middle cerebral arterY – Registry

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Trial Acronym

[---]*

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URL of the Trial

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Brief Summary in Lay Language

Patients suffering from space-occupying ischemic infarction of the middle cerebral artery, so called 'malign MCA infarction' have a poor prognosis despite intensive care treatment. Early decompressive surgery showed a reduction of lethality of more than 40%. But 40% survive with a severe disability, with 10% being bedridden. To operate on which patient is still a matter of debate particularly in older patients and infarction of the dominant hemisphere. Another key question is timing and prognostic factors of clinical outcome. The numbers of patients in the randomized trials is to low answer these relevant questions. It remains unclear how patients are treated in clinical routine. We want to know which clinical outcome is 'acceptable' for our patients facing a disease which can not be survived without any permanent disability.
The study will measure implementation of guideline therapy and therapy where there is no evidence with pre-defined quality indicators. The study help to design investigator initiated interventional studies to improve the therapy of malignant MCA-infarction.

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Brief Summary in Scientific Language

Patients suffering from space-occupying ischemic infarction of the middle cerebral artery, so called 'malign MCA infarction' have a poor prognosis despite intensive care treatment. Early decompressive surgery showed a reduction of lethality of more than 40%. But 40% survive with a severe disability, with 10% being bedridden. To operate on which patient is still a matter of debate particularly in older patients and infarction of the dominant hemisphere. Another key question is timing and prognostic factors of clinical outcome. The numbers of patients in the randomized trials is to low answer these relevant questions. It remains unclear how patients are treated in clinical routine. We want to know which clinical outcome is 'acceptable' for our patients facing a disease which can not be survived without any permanent disability.
The study will measure implementation of guideline therapy and therapy where there is no evidence with pre-defined quality indicators. The study help to design investigator initiated interventional studies to improve the therapy of malignant MCA-infarction.

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Organizational Data

  •   DRKS00000624
  •   2011/02/14
  •   [---]*
  •   yes
  •   Approved
  •   EA4/108/09, Ethik-Kommission der Charité -Universitätsmedizin Berlin-
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Secondary IDs

  •   U1111-1119-4279 
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Health Condition or Problem studied

  •   I63.5 -  Cerebral infarction due to unspecified occlusion or stenosis of cerebral arteries
  •   [---]* -  [---]*
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Interventions/Observational Groups

  •   Observation group 1: Patients fullfilling the inclusion criteria treated with decompressive surgery
  •   Observation group 2: Patients fullfilling the inclusion criteria treated conservatively
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Other
  •   Open (masking not used)
  •   [---]*
  •   Other
  •   Other
  •   Other
  •   N/A
  •   [---]*
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Primary Outcome

Death or severe disability after one year (mRS 5 or 6 vs. 0-4)

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Secondary Outcome

After 1 year
1. Disability using the modified Rankin Scale (mRS)
2. Quality of life using the EuroQoL 5-D
3. Depression using the Geriatric Depression Scale (GDS)
4. Surgical complications
5. Median survival and mortality
6. Treatment: Retrospective consent

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Countries of Recruitment

  •   Germany
  •   Austria
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Locations of Recruitment

  • [---]*
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Recruitment

  •   Actual
  •   2010/01/25
  •   1000
  •   Multicenter trial
  •   International
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

1.Clinical signs and symptoms of an unilateral infarction of the middle cerebral artery (MCA)
2. cCT: Evidence of an unilateral ischemic infarction of the MCA, involving at least 50% of the territory or more.
3. MRI: No evidence of a relevant mismatch
4. With or without involvement of ACA and PCA territory
5. Informed consent signed by patient or legal representative

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Exclusion Criteria

Additional brain injury at the same time or contemporary (e.g. traumatic brain injury)

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Addresses

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    • Ostalb-Klinikum Aalen
    • Mr.  PD Dr. med. MSc.  Eric  Jüttler 
    • Am Kälbesrain 1
    • 73430  Aalen
    • Germany
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    • Universitäts- und Rehabilitationskliniken Ulm, RKU, Klinik für Neurologie
    • Mr.  Dr. med. M.Sc.  Hermann  Neugebauer 
    • Oberer Eselsberg 45
    • 89081  Ulm
    • Germany
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    • Centrum für Schlaganfallforschung Berlin- CSB
    • Ms.  Miriam  Bauer 
    • Charitéplatz 1
    • 10117   Berlin
    • Germany
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Sources of Monetary or Material Support

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    • Centrum für Schlaganfallforschung Berlin- CSB
    • Charitéplatz 1
    • 10117   Berlin
    • Germany
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Status

  •   Recruiting complete, follow-up continuing
  •   [---]*
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Trial Publications, Results and other Documents

  •   Protokoll und CRF auf Anfrage / protocoll and CRF by request (E-Mail)
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