title: The Cologne stroke experience: safety and outcome in 450 patients treated with intravenous thrombolysis.
abstract: BACKGROUND
  Predictors of outcome and safety in intravenous thrombolysis within 3 h in clinical routine is a matter of ongoing debate. Available reports contain small patient numbers or summarize heterogeneous multicenter data.
  
  
  METHODS
  Four hundred and fifty patients received intravenous thrombolysis within 3 h after stroke. Pretreatment NIHSS score and detailed medical history were analyzed. Noncontrast CT was performed before thrombolysis, 24-36 h later and in case of clinical deterioration. Symptomatic intracranial hemorrhage (SICH; any bleeding with an NIHSS increase of > or =4 points) and clinical outcome (modified Rankin Scale, mRS) after 3 months were recorded. Logistic regression identified parameters predictive of independence (mRS 0-2) and SICH.
  
  
  RESULTS
  Median onset to admission, door to needle and onset to treatment time was 75, 50 and 135 min, respectively. Direct presentation by emergency service (64%) was the fastest way of referral. Median pretreatment NIHSS was 11 points. Independence (mRS 0-2) was reached by 53%. Mortality was 11% (7% intracerebral, 4% extracerebral complications). Logistic regression identified low NIHSS, low age and absent diabetes as predictors of independence. Overall hemorrhagic complications and SICH were found in 18 and 4% of the patients, respectively. Extracerebral bleeding complications and allergic reactions were found in 3 and 1%, respectively.
  
  
  CONCLUSIONS
  This largest single center report presents a sample in the range of the 3 h rt-PA cohort of all randomized controlled trials. Outcome was comparable to randomized studies with a higher rate of independence and a lower rate of mortality and SICH.
authors.affiliation: Max Planck Institute for Neurological Research, University of Cologne, Cologne, Germany. j.sobesky@nf.mpg.de
authors.forename: Jan
authors.initials: J
authors.lastname: Sobesky
authors.forename: Monika
authors.initials: M
authors.lastname: Frackowiak
authors.forename: Olivier
authors.initials: O
authors.lastname: Zaro Weber
authors.forename: Moritz
authors.initials: M
authors.lastname: Hahn
authors.forename: Walter
authors.initials: W
authors.lastname: Möller-Hartmann
authors.forename: Jobst
authors.initials: J
authors.lastname: Rudolf
authors.forename: Michael
authors.initials: M
authors.lastname: Neveling
authors.forename: Martin
authors.initials: M
authors.lastname: Grond
authors.forename: Susanne
authors.initials: S
authors.lastname: Schmulling
authors.forename: Andreas
authors.initials: A
authors.lastname: Jacobs
authors.forename: Wolf-Dieter
authors.initials: WD
authors.lastname: Heiss
mesh_terms: D000203:Activities of Daily Living; D000368:Aged; D005260:Female; D005343:Fibrinolytic Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D005858:Germany; D006470:Hemorrhage / Q000139:chemically induced; D006801:Humans; D007262:Infusions, Intravenous; D020300:Intracranial Hemorrhages / Q000139:chemically induced; D016015:Logistic Models; D008297:Male; D008875:Middle Aged; D016017:Odds Ratio; D011994:Recombinant Proteins / Q000627:therapeutic use; D020127:Recovery of Function / Q000187:drug effects; D018570:Risk Assessment; D012307:Risk Factors; D012720:Severity of Illness Index; D020521:Stroke / Q000188:drug therapy* / Q000401:mortality / Q000503:physiopathology; D015912:Thrombolytic Therapy; D013997:Time Factors; D010959:Tissue Plasminogen Activator / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D016896:Treatment Outcome
chemical_list: D005343:Fibrinolytic Agents; D011994:Recombinant Proteins; D010959:Tissue Plasminogen Activator