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Register:	German Clinical Trials Register
Last refreshed on:	21 May 2024
Main ID:	DRKS00000624
Date of registration:	14/02/2011
Prospective Registration:	No
Primary sponsor:	Ostalb-Klinikum Aalen
Public title:	DEcompressive Surgery for the Treatment of malignant INfarction of the middle cerebral arterY – Registry
Scientific title:	DEcompressive Surgery for the Treatment of malignant INfarction of the middle cerebral arterY – Registry
Date of first enrolment:	25/01/2010
Target sample size:	1000
Recruitment status:	Complete
URL:	http://drks.de/search/en/trial/DRKS00000624
Study type:	observational
Study design:	Allocation: ; Masking: ; Control: ; Assignment: ; Study design purpose: other
Phase:

Countries of recruitment
Austria	Germany

Contacts

Name:	Miriam Bauer
Address:	Charitéplatz 1 10117 Berlin Germany
Telephone:
Email:	miriam.bauer@charite.de
Affiliation:	Centrum für Schlaganfallforschung Berlin- CSB

Name:	Hermann Neugebauer
Address:	Oberer Eselsberg 45 89081 Ulm Germany
Telephone:	0049 731 177 5227
Email:	hermann.neugebauer@uni-ulm.de
Affiliation:	Universitäts- und Rehabilitationskliniken Ulm, RKU, Klinik für Neurologie

Key inclusion & exclusion criteria

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

Age minimum: 18 Years
Age maximum: None
Gender: All

Health Condition(s) or Problem(s) studied

Cerebral infarction due to unspecified occlusion or stenosis of cerebral arteries

I63.5

Intervention(s)

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

Primary Outcome(s)

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

Secondary Outcome(s)

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

Secondary ID(s)

U1111-1119-4279

Source(s) of Monetary Support

Centrum für Schlaganfallforschung Berlin- CSB

Secondary Sponsor(s)

Ethics review

Status: Approved
Approval date: 08/12/2010
Contact:

ethikkommission@charite.de

Ethikkommission der Charité – Universitätsmedizin Berlin

(+49)30-450517222

ethikkommission@charite.de

Results

Results available:
Date Posted:
Date Completed:
URL:	http://drks.de/search/en/trial/DRKS00000624#studyResults

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