title: DEcompressive surgery Plus hypoTHermia for Space-Occupying Stroke (DEPTH-SOS): a protocol of a multicenter randomized controlled clinical trial and a literature review.
abstract: BACKGROUND
  Although 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.
  
  
  OBJECTIVE
  The 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.
  
  
  METHODS
  The DEcompressive surgery Plus hypoTHermia for Space-Occupying Stroke is a prospective, multicenter, open, two-arm (1:1) comparative, randomized, controlled trial.
  
  
  RESULTS
  The 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.
  
  
  CONCLUSIONS
  The 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.
authors.affiliation: Center for Stroke Research Berlin (CSB), Charité-Universitätsmedizin, Berlin, Germany. hermann.neugebauer@charite.de
authors.forename: Hermann
authors.initials: H
authors.lastname: Neugebauer
authors.forename: Rainer
authors.initials: R
authors.lastname: Kollmar
authors.forename: Wolf-Dirk
authors.initials: WD
authors.lastname: Niesen
authors.forename: Julian
authors.initials: J
authors.lastname: Bösel
authors.forename: Hauke
authors.initials: H
authors.lastname: Schneider
authors.forename: Carsten
authors.initials: C
authors.lastname: Hobohm
authors.forename: Klaus
authors.initials: K
authors.lastname: Zweckberger
authors.forename: Peter U
authors.initials: PU
authors.lastname: Heuschmann
authors.forename: Peter D
authors.initials: PD
authors.lastname: Schellinger
authors.forename: Eric
authors.initials: E
authors.lastname: Jüttler
mesh_terms: D000293:Adolescent; D000328:Adult; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D055815:Young Adult; D019299:Decompression, Surgical / Q000379:methods; D004185:Disability Evaluation; D007036:Hypothermia, Induced / Q000379:methods; D020244:Infarction, Middle Cerebral Artery / Q000209:etiology / Q000628:therapy; D017063:Outcome Assessment, Health Care; D012720:Severity of Illness Index; D020521:Stroke / Q000150:complications / Q000401:mortality / Q000628:therapy; D015337:Multicenter Studies as Topic; D016032:Randomized Controlled Trials as Topic