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Safety of routine IV thrombolysis between 3 and 4.5 h after ischemic stroke.

AbstractBACKGROUND: The administration of tissue plasminogen activator (t-PA) has been proven effective for ischemic stroke within 3 h after onset. A pooled-analysis of six trials showed that intravenous t-PA still improves outcome when given between 3 to 4.5 h after stroke onset. On the basis of this pooled analysis, t-PA was also routinely offered to our patients between 3-4.5 h. We report the safety and clinical features of this group together with the features of the group given t-PA within 3 h. METHODS: Prospectively patient characteristics, stroke severity, stroke subtype, incidence of symptomatic intracerebral hemorrhage (SICH), in-hospital mortality, and 3-months modified Rankin Scale scores (mRS) were registered. Data was analyzed separately for patients treated within 3 h (early group) and those treated between 3-4.5 h (late group). RESULTS: Among 176 patients who underwent intravenous thrombolysis, 101 were treated in the early group and 75 in the late group. Six (5.9%; 95% CI 2.8%-12.3%) patients in the early group and 4 (5.3%; 95% CI 2.2%-12.9%) in the late group developed SICH (p=1.0). In the early group 13 (12.9%; 95% CI 7.7%-20.8%) patients died within 7 days after admission, compared to 5 (6.7%; 95% CI 3.0%-14.7%) in the late group (p=0.179). In the early group 44 (43.6%; 95% CI 43.3%-53.3%) were independent (mRS< or =2) at three months, compared to 36 (48.0%; 95% CI 37.0%-59.1%) in the late group (p=0.559). CONCLUSION: Our data show no trend of decreased safety of thrombolysis beyond 3 h. Due to a small sample size a harmful effect cannot be excluded but seems unlikely.
AuthorsM Uyttenboogaart, P C A J Vroomen, R E Stewart, J De Keyser, G J Luijckx (Affiliation: Department of Neurology, University Medical Center Groningen, Hanzeplein 1, 9700 RB Groningen, The Netherlands. m.uyttenboogaart at neuro.umcg.nl)
JournalJournal of the neurological sciences (J Neurol Sci) Vol. 254 Issue 1-2 Pg. 28-32 (Mar 15 2007) ISSN: 0022-510X Netherlands
PMID17257623 (Publication Type: Clinical Trial, Comparative Study, Journal Article, Research Support, Non-U.S. Gov't)
Chemical References
  • Fibrinolytic Agents
  • Tissue Plasminogen Activator
Topics
  • Adult
  • Aged
  • Aged, 80 and over
  • Brain Ischemia (drug therapy, mortality, physiopathology)
  • Cerebral Hemorrhage (chemically induced, prevention & control, radiography)
  • Drug Administration Schedule
  • Female
  • Fibrinolytic Agents (administration & dosage, adverse effects)
  • Humans
  • Injections, Intravenous (adverse effects)
  • Male
  • Predictive Value of Tests
  • Prospective Studies
  • Risk Assessment
  • Risk Factors
  • Stroke (drug therapy, mortality, physiopathology)
  • Thrombolytic Therapy (adverse effects, mortality, standards)
  • Time Factors
  • Tissue Plasminogen Activator (administration & dosage, adverse effects)
  • Tomography, X-Ray Computed (standards)
  • Treatment Outcome