Thrombolysis for acute stroke in routine clinical practice

Arch Intern Med. 2002 Sep 23;162(17):1994-2001. doi: 10.1001/archinte.162.17.1994.


Background: Studies have demonstrated that thrombolytic therapy for acute stroke can be given safely and effectively in study settings with experienced clinicians, but the patient outcomes associated with thrombolytic therapy in routine clinical practice require investigation.

Objectives: To compare outcomes among patients given intravenous thrombolysis in routine clinical practice with the results of the National Institute of Neurological Disorders and Stroke rt-PA Study (NINDS cohort) and to examine whether protocol deviations are associated with adverse events.

Methods: Retrospective cohort of community-based patients given thrombolysis for acute stroke from May 1, 1996, through December 31, 1998, in 16 Connecticut hospitals (Connecticut cohort).

Results: Forty-two (67%) of 63 patients in the Connecticut cohort had at least 1 major protocol deviation, and 61 (97%) had major or minor protocol deviations. Overall, the in-hospital mortality was higher in the Connecticut cohort (16/63 [25%]) compared with the NINDS cohort (40/312 [13%]; P =.01). The serious extracranial hemorrhage rate was also higher for the Connecticut cohort (8/63 [13%] vs 5/312 [2%]; P =.001). Patients in the Connecticut cohort without major protocol deviations had outcomes similar to those in the NINDS cohort; however, patients in the Connecticut cohort with major protocol deviations had higher rates of in-hospital mortality (13/42 [31%] vs 40/312 [13%]; P =.002) and serious extracranial hemorrhage (7/42 [17%] vs 5/312 [2%]; P =.001).

Conclusions: Protocol deviations occur commonly when thrombolytic therapy is given to stroke patients in routine clinical practice. Patients who receive thrombolysis with major protocol deviations have higher rates of in-hospital mortality and serious extracranial hemorrhage than patients in the NINDS cohort.

Publication types

  • Clinical Trial
  • Comparative Study
  • Research Support, Non-U.S. Gov't
  • Research Support, U.S. Gov't, Non-P.H.S.

MeSH terms

  • Adult
  • Aged
  • Aged, 80 and over
  • Clinical Protocols
  • Cohort Studies
  • Connecticut / epidemiology
  • Female
  • Hospital Mortality
  • Humans
  • Male
  • Middle Aged
  • Retrospective Studies
  • Severity of Illness Index
  • Stroke / drug therapy*
  • Stroke / mortality
  • Thrombolytic Therapy*
  • Tissue Plasminogen Activator / adverse effects
  • Tissue Plasminogen Activator / therapeutic use*
  • Treatment Outcome


  • Tissue Plasminogen Activator