Safety of Intravenous Thrombolytic Use in Four Emergency Departments Without Acute Stroke Teams

• Published in: Academic emergency medicine 2010-10, Vol.17 (10), p.1062-1071
• Main Authors: Scott, Phillip A., Frederiksen, Shirley M., Kalbfleisch, John D., Xu, Zhenzhen, Meurer, William J., Caveney, Angela F., Sandretto, Annette, Holden, Ann B., Haan, Mary N., Hoeffner, Ellen G., Ansari, Sameer A., Lambert, David P., Jaggi, Michael, Barsan, William G., Silbergleit, Robert
• Format: Article
• Language: English
• Subjects: Aged; Aged, 80 and over; Ambulatory Care - methods; Ambulatory Care - standards; Cerebral Hemorrhage - chemically induced; Cerebral Hemorrhage - diagnostic imaging; Cerebral Hemorrhage - mortality; Clinical medicine; Cohort Studies; Confidence Intervals; Dose-Response Relationship, Drug; Drug Administration Schedule; Drug-Related Side Effects and Adverse Reactions; emergency department; Emergency medical care; Emergency Medicine - standards; Emergency Service, Hospital; Female; Fibrinolytic Agents - adverse effects; Fibrinolytic Agents - therapeutic use; Hospital Mortality - trends; Humans; ICH; Infusions, Intravenous; Male; Michigan - epidemiology; Middle Aged; Odds Ratio; Parenteral nutrition; Patient safety; Practice Guidelines as Topic; Prognosis; Proportional Hazards Models; Reference Values; Retrospective Studies; Risk Assessment; safety; stroke; Stroke - diagnosis; Stroke - drug therapy; Stroke - mortality; Survival Analysis; Thrombolytic drugs; Thrombolytic Therapy - adverse effects; Thrombolytic Therapy - methods; tissue plasminogen activator; Tissue Plasminogen Activator - adverse effects; Tissue Plasminogen Activator - therapeutic use; Tomography, X-Ray Computed - methods; Treatment Outcome
• ISSN: 1069-6563; 1553-2712
• DOI: 10.1111/j.1553-2712.2010.00868.x

Objectives:  The objective was to evaluate safety of intravenous (IV) tissue plasminogen activator (tPA) delivered without dedicated thrombolytic stroke teams. Methods:  This was a retrospective, observational study of patients treated between 1996 and 2005 at four southeastern Michigan hospital emergency departments (EDs) with a prospectively defined comparison to the National Institute of Neurological Disorders and Stroke (NINDS) tPA stroke study cohort. Main outcome measures were mortality, intracerebral hemorrhage (ICH), systemic hemorrhage, neurologic recovery, and guideline violations. Results:  A total of 273 consecutive stroke patients were treated by 95 emergency physicians (EPs) using guidelines and local neurology resources. One‐year mortality was 27.8%. Unadjusted Cox model relative risk (RR) of mortality compared to the NINDS tPA treatment and placebo groups was 1.20 (95% confidence interval [CI] = 0.87 to 1.64) and 1.04 (95% CI = 0.76 to 1.41), respectively. The rate of significant ICH by computed tomography (CT) criteria was 6.6% (odds ratio [OR] = 1.03, 95% CI = 0.56 to 1.90 compared to the NINDS tPA treatment group). The proportions of symptomatic ICH by two other prespecified sets of clinical criteria were 4.8 and 7.0%. The rate of any ICH within 36 hours of treatment was 9.9% (RR = 0.94, 95% CI = 0.58 to 1.51 compared to the NINDS tPA group). The occurrence of major systemic hemorrhage (requiring transfusion) was 1.1%. Functional recovery by the modified Rankin Scale score (mRS = 0 to 2) at discharge occurred in 38% of patients with a premorbid disability mRS