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Open Access Study protocol

DEcompressive Surgery for the Treatment of malignant INfarction of the middle cerebral arterY - Registry (DESTINY-R): design and protocols

Hermann Neugebauer1*, Peter U Heuschmann2 and Eric Jüttler1

Author Affiliations

1 Center for Stroke Research Berlin (CSB), Charité - Universitätsmedizin Berlin, Augustenburger Platz 1, 13353, Berlin, Germany

2 Institute for Clinical Epidemiology and Biometry, Center for Clinical Studies, and Comprehensive Heart Failure Center, University of Würzburg, Petrinistr. 33a, 97080, Würzburg, Germany

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BMC Neurology 2012, 12:115  doi:10.1186/1471-2377-12-115

Published: 2 October 2012

Abstract

Background

Randomized controlled trials (RCT) on the treatment of severe space-occupying infarction of the middle cerebral artery (malignant MCA infarction) showed that early decompressive hemicraniectomy (DHC) is life saving and improves outcome without promoting most severe disablity in patients aged 18–60 years. It is, however, unknown whether the results obtained in the randomized trials are reproducible in a broader population in and apart from an academical setting and whether hemicraniectomy has been implemented in clinical practice as recommended by national and international guidelines. In addition, they were not powered to answer further relevant questions, e.g. concerning the selection of patients eligible for and the timing of hemicraniectomy. Other important issues such as the acceptance of disability following hemicraniectomy, the existence of specific prognostic factors, the value of conservative therapeutic measures, and the overall complication rate related to hemicraniectomy have not been sufficiently studied yet.

Methods/Design

DESTINY-R is a prospective, multicenter, open, controlled registry including a 12 months follow-up. The only inclusion criteria is unilateral ischemic MCA stroke affecting more than 50% of the MCA-territory. The primary study hypothesis is to confirm the results of the RCT (76% mRS ≤ 4 after 12 months) in the subgroup of patients additionally fulfilling the inclusion cirteria of the RCT in daily routine. Assuming a calculated proportion of 0.76 for successes and a sample size of 300 for this subgroup, the width of the 95% CI, calculated using Wilson's method, will be 0.096 with the lower bound 0.709 and the upper bound 0.805.

Discussion

The results of this study will provide information about the effectiveness of DHC in malignant MCA infarction in a broad population and a real-life situation in addition to and beyond RCT. Further prospectively obtained data will give crucial information on open questions and will be helpful in the plannig of upcomming treatment studies.

Trial registration

(ICTRP and DRKS): DRKS00000624

Keywords:
Decompressive surgery; Hemicraniectomy; Ischaemic stroke; Malignant MCA infarct; Registry