title: Endovascular Reperfusion and Cooling in Cerebral Acute Ischemia (ReCCLAIM I).
abstract: BACKGROUND
  The efficacy of hypothermia as a neuroprotectant has yet to be demonstrated in acute ischemic stroke. We conducted a phase I pilot study to assess the feasibility and safety of performing intravascular hypothermia after definitive intra-arterial reperfusion therapy (IAT).
  
  
  METHODS
  ReCCLAIM (Reperfusion and Cooling in Cerebral Acute Ischemia) is a prospective single-arm open-label clinical trial conducted between May and August 2012 at Grady Memorial Hospital. Twenty patients with Alberta Stroke Program Early CT Score (ASPECTS) 5-7 and NIH Stroke Scale (NIHSS) score > 13 were enrolled and treated with intravascular cooling immediately after IAT. The incidence of pneumonia, deep vein thrombosis, cardiac arrhythmias and postoperative hemorrhages was documented for the entire length of stay. Secondary outcomes included blood-brain barrier (BBB) breakdown on gadolinium-enhanced MRIs and 90-day modified Rankin scores (mRS).
  
  
  RESULTS
  The mean age, median NIHSS score and median final infarct volume were 59.7 ± 14.6 years, 19 (IQR16-22) and 78 cm(3) (IQR 16-107), respectively. The average time to the target temperature (33 °C) was 64 ± 50 min. Intracranial hemorrhages were found in three patients, of which one was symptomatic. Evidence of BBB breakdown was observed on 3 of 14 MRIs (21%). Six patients died due to withdrawal of care, whereas six patients (30%) achieved mRS of 0-2 at 90 days. In a binary logistical regression model comparing ReCCLAIM patients with 68 historical controls at our institution, hypothermia was protective against intracerebral hemorrhages (OR 0.09, 95% CI 0.02 to 0.56; p<0.01).
  
  
  CONCLUSIONS
  Hypothermia can be safely performed after definitive IAT in patients with large pretreatment core infarcts. A phase II study randomizing patients to hypothermia or normothermia is needed to properly assess the efficacy of hypothermia as a neuroprotectant for reperfusion injury.
  
  
  BACKGROUND
  NCT01585597.
authors.affiliation: Department of Neurology, Emory University School of Medicine, Marcus Stroke and Neuroscience Center, Grady Memorial Hospital, Atlanta, Georgia, USA.
authors.forename: Christopher M
authors.initials: CM
authors.lastname: Horn
authors.forename: Chung-Huan J
authors.initials: CH
authors.lastname: Sun
authors.forename: Raul G
authors.initials: RG
authors.lastname: Nogueira
authors.forename: Vishal N
authors.initials: VN
authors.lastname: Patel
authors.forename: Arun
authors.initials: A
authors.lastname: Krishnan
authors.forename: Brenda A
authors.initials: BA
authors.lastname: Glenn
authors.forename: Samir R
authors.initials: SR
authors.lastname: Belagaje
authors.forename: Tommy T
authors.initials: TT
authors.lastname: Thomas
authors.forename: Aaron M
authors.initials: AM
authors.lastname: Anderson
authors.forename: Michael R
authors.initials: MR
authors.lastname: Frankel
authors.forename: Kiva M
authors.initials: KM
authors.lastname: Schindler
authors.forename: Rishi
authors.initials: R
authors.lastname: Gupta
mesh_terms: D000208:Acute Disease; D000368:Aged; D002545:Brain Ischemia / Q000175:diagnosis* / Q000628:therapy*; D015331:Cohort Studies; D057510:Endovascular Procedures / Q000379:methods*; D005260:Female; D006801:Humans; D007036:Hypothermia, Induced / Q000379:methods*; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D015424:Reperfusion / Q000379:methods*