title: Frequency and predictors of symptomatic intracerebral hemorrhage in patients with ischemic stroke treated with recombinant tissue plasminogen activator outside clinical trials.
abstract: BACKGROUND
  To determine the frequency and predictors of symptomatic intracerebral hemorrhage (SICH) in patients treated with recombinant tissue plasminogen activator (rt-PA).
  
  
  METHODS
  We reviewed the databases of 7 tertiary hospitals that treated ischemic stroke patients with intravenous rt-PA. We recorded demographic data, vascular risk factors, time between onset and treatment, dose, the NIHSS score, body temperature, blood pressure, platelet count, blood glucose, antiplatelet treatment, and CT data. We also registered the study protocol used for treatment and deviations from the accepted protocol. A control CT was performed on all patients. SICH was diagnosed if a parenchymal hematoma was detected within the 36 h after rt-PA and was associated with an increase of > or =4 in the NIHSS score. Bivariate analyses were performed followed by a logistic regression analysis.
  
  
  RESULTS
  A total of 347 patients were studied, whose mean age was 68 +/- 10.9 years; 56% were men. Thirty-two patients (9.2%) exhibited a parenchymal hematoma, and 8 patients (2.3%) suffered a SICH. Patients with SICH had a higher frequency of previous transient ischemic attack (p = 0.04), early signs of ischemia (p = 0.003), hyperdense arterial sign (p = 0.008), and deviations (p = 0.002). Early signs of ischemia (OR 8.5, 95% CI 1.6-45.4, p = 0.01) and deviation from the protocol (OR 11.1, 95% CI 2.4-50, p = 0.002) were independent predictors of SICH.
  
  
  CONCLUSIONS
  SICH is infrequent in patients with ischemic stroke treated with rt-PA outside of a clinical trial. Its frequency increases in the presence of early signs of ischemia on the non-contrast CT scan and deviations from the recommended protocol.
authors.affiliation: Department of Neurology, Hospital de la Santa Creu i Sant Pau, Barcelona, Spain. jmarti@santpau.es
authors.forename: Joan
authors.initials: J
authors.lastname: Martí-Fàbregas
authors.forename: Yolanda
authors.initials: Y
authors.lastname: Bravo
authors.forename: Dolores
authors.initials: D
authors.lastname: Cocho
authors.forename: Josep-Lluis
authors.initials: JL
authors.lastname: Martí-Vilalta
authors.forename: Jordi
authors.initials: J
authors.lastname: Díaz-Manera
authors.forename: Luis
authors.initials: L
authors.lastname: San Román
authors.forename: Mireia
authors.initials: M
authors.lastname: Puig
authors.forename: Miguel
authors.initials: M
authors.lastname: Blanco
authors.forename: Mar
authors.initials: M
authors.lastname: Castellanos
authors.forename: Mónica
authors.initials: M
authors.lastname: Millán
authors.forename: Jaume
authors.initials: J
authors.lastname: Roquer
authors.forename: Víctor
authors.initials: V
authors.lastname: Obach
authors.forename: José
authors.initials: J
authors.lastname: Maestre
mesh_terms: D000368:Aged; D002543:Cerebral Hemorrhage / Q000139:chemically induced* / Q000000981:diagnostic imaging / Q000453:epidemiology; D005260:Female; D005343:Fibrinolytic Agents / Q000009:adverse effects*; D019983:Guideline Adherence; D006801:Humans; D002546:Ischemic Attack, Transient / Q000150:complications*; D016015:Logistic Models; D008297:Male; D008875:Middle Aged; D016017:Odds Ratio; D017410:Practice Guidelines as Topic; D011237:Predictive Value of Tests; D011994:Recombinant Proteins / Q000009:adverse effects; D012189:Retrospective Studies; D018570:Risk Assessment; D012307:Risk Factors; D013030:Spain / Q000453:epidemiology; D020521:Stroke / Q000188:drug therapy* / Q000209:etiology; D015912:Thrombolytic Therapy / Q000009:adverse effects*; D013997:Time Factors; D010959:Tissue Plasminogen Activator / Q000009:adverse effects*; D014057:Tomography, X-Ray Computed; D016896:Treatment Outcome
chemical_list: D005343:Fibrinolytic Agents; D011994:Recombinant Proteins; D010959:Tissue Plasminogen Activator