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DEcompressive Surgery plus hypoTHermia for Space-Occupying Stroke (DEPTH-SOS): a protocol of a multicenter randomized controlled clinical trial and a literature review

RationaleAlthough decompressive hemicraniectomy clearly reduces mortality in severe space-occupying middle cerebral artery infarction (so-called malignant middle cerebral artery infarction), every fifth patient still dies in the acute phase and every third patient is left with moderate to severe dis...

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Main Authors: Neugebauer, Hermann (Author) , Kollmar, Rainer (Author) , Niesen, Wolf-Dirk (Author) , Bösel, Julian (Author) , Schneider, Hauke (Author) , Hobohm, Carsten (Author) , Zweckberger, Klaus (Author) , Heuschmann, Peter U. (Author) , Schellinger, Peter D. (Author) , Jüttler, Eric (Author)
Format: Article (Journal)
Language:English
Published: June 20, 2013
In: International journal of stroke
Year: 2013, Volume: 8, Issue: 5, Pages: 383-387
ISSN:1747-4949
DOI:10.1111/ijs.12086
Online Access:Verlag, lizenzpflichtig, Volltext: https://doi.org/10.1111/ijs.12086
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Author Notes:Hermann Neugebauer, Rainer Kollmar, Wolf-Dirk Niesen, Julian Bösel, Hauke Schneider, Carsten Hobohm, Klaus Zweckberger, Peter U. Heuschmann, Peter D. Schellinger, and Eric Jüttler for the DEPTH-SOS Study Group and the IGNITE Study Group
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Summary:RationaleAlthough decompressive hemicraniectomy clearly reduces mortality in severe space-occupying middle cerebral artery infarction (so-called malignant middle cerebral artery infarction), every fifth patient still dies in the acute phase and every third patient is left with moderate to severe disability. Therapeutic hypothermia is a neuroprotective and antiedematous treatment option that has shown promising effects in severe stroke. A combination of both treatment strategies may have the potential to further reduce mortality and morbidity in malignant middle cerebral artery infarction, but needs evaluation of its efficacy within the setting of a randomized clinical trial.AimsThe DEcompressive surgery Plus hypoTHermia for Space-Occupying Stroke (DEPTH-SOS) trial aims to investigate safety and feasibility of moderate therapeutic hypothermia (33°C ± 1) over at least 72 h in addition to early decompressive hemicraniectomy (≤48 hours after symptom onset) in patients with malignant middle cerebral artery infarction.DesignThe DEcompressive surgery Plus hypoTHermia for Space-Occupying Stroke is a prospective, multicenter, open, two-arm (1:1) comparative, randomized, controlled trial.Study outcomesThe primary end-point is mortality at day 14. The secondary end-points include functional outcome at day 14 and at 12 months follow-up, and complications related to hypothermia.DiscussionThe results of this trial will provide data on safety and feasibility of moderate hypothermia in addition to decompressive hemicraniectomy in malignant middle cerebral artery infarction. Furthermore, efficacy data on early mortality and long-term functional outcome will be obtained, forming the basis of subsequent trials.
Item Description:Gesehen am 08.12.2021
Physical Description:Online Resource
ISSN:1747-4949
DOI:10.1111/ijs.12086

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