title: Mild hypothermia after intravenous thrombolysis in patients with acute stroke: a randomized controlled trial.
abstract: OBJECTIVE
  Hypothermia improves outcome in resuscitated patients and newborns with hypoxic brain injury. We studied the safety and feasibility of mild hypothermia in awake patients with stroke after intravenous thrombolysis.
  
  
  METHODS
  Patients were randomized 1:1 to mild hypothermia (35°C) or to standard stroke unit care within 6 hours of symptom onset. Hypothermia was induced with a surface-cooling device and cold saline infusions. Active cooling was restrained gradually after 12 hours at <35.5°C. The primary outcome measure was the number of patients with <36°C body temperature for >80% of the 12-hour cooling period.
  
  
  RESULTS
  We included 36 patients with a median of National Institutes of Health Stroke Scale score of 9 one hour after thrombolysis. Fifteen of 18 (83%) patients achieved the primary end point. Sixteen (89%) patients reached <35.5°C in a median time of 10 hours (range, 7-16 hours) from symptom onset, spent 10.5 hours (1-17 hours) in hypothermia, and were back to normothermia in 23 hours (15-29 hours). Few serious adverse events were more common in the hypothermia group. At 3 months, 7 patients (39%) in both groups had good outcome (modified Ranking Scale, 0-2), whereas poor outcome (modified Ranking Scale, 4-6) was twice as common in the normothermia group (44% versus 22%).
  
  
  CONCLUSIONS
  Mild hypothermia with a surface-cooling device in an acute stroke unit is safe and feasible in thrombolyzed, spontaneously breathing patients with stroke, despite the adverse events.
  
  
  BACKGROUND
  http://www.clinicaltrials.gov. Unique identifier: NCT00987922.
authors.affiliation: From the Departments of Neurology (K.P., M.T., S.M., A.M., T.T., M.K.), and Anesthesiology (K.-M.K.), Helsinki University Central Hospital, Helsinki, Finland; and the Departments of Medicine and Florey, University of Melbourne, Parkville, Australia (A.M.).
authors.forename: Katja
authors.initials: K
authors.lastname: Piironen
authors.forename: Marjaana
authors.initials: M
authors.lastname: Tiainen
authors.forename: Satu
authors.initials: S
authors.lastname: Mustanoja
authors.forename: Kirsi-Maija
authors.initials: KM
authors.lastname: Kaukonen
authors.forename: Atte
authors.initials: A
authors.lastname: Meretoja
authors.forename: Turgut
authors.initials: T
authors.lastname: Tatlisumak
authors.forename: Markku
authors.initials: M
authors.lastname: Kaste
mesh_terms: D000368:Aged; D001794:Blood Pressure / Q000502:physiology; D001831:Body Temperature / Q000502:physiology; D003627:Data Interpretation, Statistical; D005240:Feasibility Studies; D005260:Female; D005343:Fibrinolytic Agents / Q000008:administration & dosage / Q000627:therapeutic use; D006801:Humans; D007036:Hypothermia, Induced / Q000009:adverse effects / Q000379:methods*; D007275:Injections, Intravenous; D008297:Male; D008875:Middle Aged; D061214:Patient Safety; D012307:Risk Factors; D020521:Stroke / Q000628:therapy*; D015912:Thrombolytic Therapy / Q000379:methods*; D010959:Tissue Plasminogen Activator / Q000008:administration & dosage / Q000627:therapeutic use; D014057:Tomography, X-Ray Computed; D016896:Treatment Outcome
chemical_list: D005343:Fibrinolytic Agents; D010959:Tissue Plasminogen Activator
keywords: hypothermia; ischemic stroke; thrombolytic therapy