title: No increased risk of symptomatic intracerebral hemorrhage after thrombolysis in patients with European Cooperative Acute Stroke Study (ECASS) exclusion criteria.
abstract: OBJECTIVE
  The European Cooperative Acute Stroke Study (ECASS) III trial used additional exclusion criteria not present in current guidelines for thrombolytic therapy in the United States (age >80 years; National Institutes of Health Stroke Scale >25, combination of previous stroke and diabetes, aggressive measures required to control blood pressure [intravenous infusion], and oral anticoagulant treatment). We tested the hypothesis that thrombolysis is not safe in patients with 1 of the additional exclusion criteria.
  
  
  METHODS
  All patients treated with intravenous tissue-type plasminogen activator for acute stroke at our center between June 2006 and June 2010 were identified (n=191), and stratified based on presence of each of the exclusion criteria. Primary outcomes were rate of symptomatic intracerebral hemorrhage and in-hospital mortality. Additionally, patients with and without symptomatic intracerebral hemorrhage were analyzed for differences in baseline characteristics.
  
  
  RESULTS
  No exclusion criterion was associated with increased risk of symptomatic intracerebral hemorrhage. Symptomatic intracerebral hemorrhage was associated with atrial fibrillation (5 of 9 [55%], versus 35 of 182 [19.2%]; P=0.021), larger final infarct volume (mean 173 mL(3) versus 42 mL(3); P=0.0002), and elevated glucose (mean 166 mg/dL versus 127 mg/dL; P=0.038). There was higher mortality in patients >80 years (5 of 31 [16%] versus 6 of 160 [4%]; P=0.0186) and those with National Institutes of Health Stroke Scale >25 (2 of 5 [40%] versus 7 of 159 [4.4%]; P=0.025).
  
  
  CONCLUSIONS
  In our cohort, none of the more stringent exclusion criteria from ECASS III were associated with increased risk of symptomatic intracerebral hemorrhage. Prospective randomized studies are needed clarify the safety and efficacy of tissue-type plasminogen activator in these patients through all treatment time windows.
authors.affiliation: Department of Neurology, University of Maryland School of Medicine, 110 South Paca Street, 3rd Floor, Baltimore, MD 21201, USA. ccronin@som.umaryland.edu
authors.forename: Carolyn A
authors.initials: CA
authors.lastname: Cronin
authors.forename: Nikeith
authors.initials: N
authors.lastname: Shah
authors.forename: Tanya
authors.initials: T
authors.lastname: Morovati
authors.forename: Lisa D
authors.initials: LD
authors.lastname: Hermann
authors.forename: Kevin N
authors.initials: KN
authors.lastname: Sheth
mesh_terms: D000208:Acute Disease; D000369:Aged, 80 and over; D000933:Antifibrinolytic Agents / Q000008:administration & dosage* / Q000009:adverse effects; D005060:Europe; D005260:Female; D006801:Humans; D020300:Intracranial Hemorrhages / Q000139:chemically induced / Q000453:epidemiology*; D008297:Male; D020521:Stroke / Q000150:complications / Q000188:drug therapy* / Q000453:epidemiology*; D015912:Thrombolytic Therapy / Q000009:adverse effects / Q000379:methods*; D010959:Tissue Plasminogen Activator
chemical_list: D000933:Antifibrinolytic Agents; D010959:Tissue Plasminogen Activator