title: Safety of protocol violations in acute stroke tPA administration.
abstract: BACKGROUND
  Intravenous (IV) tissue plasminogen activator remains the only approved therapy for acute ischemic stroke (AIS) in the United States; however, less than 10% of patients receive treatment. This is partially because of the large number of contraindications, narrow treatment window, and physician reluctance to deviate from these criteria.
  
  
  METHODS
  We retrospectively analyzed consecutive patients who received IV thrombolysis at our stroke center for National Institute of Neurological Disorders and Stroke (NINDS) protocol violations and rates of symptomatic intracerebral hemorrhage (sICH). Other outcome variables included systemic hemorrhage, modified Rankin Scale at discharge, and discharge disposition.
  
  
  RESULTS
  A total of 212 patients were identified in our stroke registry between 2009 and 2011 and included in the analysis. Protocol violations occurred in 76 patients (36%). The most common violations were thrombolysis beyond 3 hours (26%), aggressive blood pressure management (15%), elevated prothrombin time (PT) or partial thromboplastin time (PTT) (6.6%), minor or resolving deficits (4.2%), unclear time of onset (3.9%), and stroke within 3 months (3%). There were no significant differences in any of the safety outcomes or discharge disposition between patients with or without protocol violations. Controlling for age, National Institutes of Health Stroke Scale on admission, and glucose on admission, there was no significant increase in sICH (odds ratio: 3.8; 95% confidence interval: .37-38.72) in the patients who had protocol violations.
  
  
  CONCLUSIONS
  Despite more than one third of patients receiving thrombolysis with protocol violations, overall rates of hemorrhage remained low and did not differ from those who did not have violations. Our data support the need to expand access to thrombolysis in AIS patients.
authors: Department of Neurology, School of Medicine, University of Alabama at Birmingham, Birmingham, Alabama; Birmingham Veterans Affairs Medical Center, Birmingham, Alabama. Electronic address: mjlyerly@uab.edu.
authors: Michael J
authors: MJ
authors: Lyerly
authors: Department of Neurology, School of Medicine, University of Alabama at Birmingham, Birmingham, Alabama; Department of Epidemiology, School of Public Health, University of Alabama at Birmingham, Birmingham, Alabama; Health Services and Outcomes Research Center for Outcome and Effectiveness Research and Education (COERE), University of Alabama at Birmingham, Birmingham, Alabama; Center for Excellence in Comparative Effectiveness Research for Eliminating Disparities, Minority Health and Health Disparities Research Center, University of Alabama at Birmingham, Birmingham, Alabama.
authors: Karen C
authors: KC
authors: Albright
authors: Department of Neurology, School of Medicine, University of Alabama at Birmingham, Birmingham, Alabama; Department of Epidemiology, School of Public Health, University of Alabama at Birmingham, Birmingham, Alabama.
authors: Amelia K
authors: AK
authors: Boehme
authors: Department of Neurology, School of Medicine, University of Alabama at Birmingham, Birmingham, Alabama.
authors: Reza
authors: R
authors: Bavarsad Shahripour
authors: Department of Neurology, School of Medicine, University of Alabama at Birmingham, Birmingham, Alabama.
authors: James T
authors: JT
authors: Houston
authors: Department of Neurology, School of Medicine, University of Alabama at Birmingham, Birmingham, Alabama.
authors: Pawan V
authors: PV
authors: Rawal
authors: Department of Neurology, School of Medicine, University of Alabama at Birmingham, Birmingham, Alabama.
authors: Niren
authors: N
authors: Kapoor
authors: Department of Neurology, School of Medicine, University of Alabama at Birmingham, Birmingham, Alabama.
authors: Muhammad
authors: M
authors: Alvi
authors: Department of Neurology, School of Medicine, University of Alabama at Birmingham, Birmingham, Alabama.
authors: April
authors: A
authors: Sisson
authors: Department of Neurology, School of Medicine, University of Alabama at Birmingham, Birmingham, Alabama; School of Nursing, University of Alabama at Birmingham, Birmingham, Alabama.
authors: Anne W
authors: AW
authors: Alexandrov
authors: Department of Neurology, School of Medicine, University of Alabama at Birmingham, Birmingham, Alabama.
authors: Andrei V
authors: AV
authors: Alexandrov
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000407:Alabama; D000959:Antihypertensive Agents / Q000592:standards / Q000627:therapeutic use; D001780:Blood Coagulation Tests / Q000592:standards; D016009:Chi-Square Distribution; D003430:Cross-Sectional Studies; D005260:Female; D005343:Fibrinolytic Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000592:standards*; D019983:Guideline Adherence / Q000592:standards; D006470:Hemorrhage / Q000139:chemically induced; D006801:Humans; D016015:Logistic Models; D008297:Male; D008875:Middle Aged; D016017:Odds Ratio; D010043:Outcome and Process Assessment, Health Care / Q000592:standards*; D010343:Patient Admission / Q000592:standards*; D061214:Patient Safety / Q000592:standards; D018579:Patient Selection; D017410:Practice Guidelines as Topic / Q000592:standards; D010818:Practice Patterns, Physicians' / Q000592:standards*; D012042:Registries; D012189:Retrospective Studies; D018570:Risk Assessment; D012307:Risk Factors; D015912:Thrombolytic Therapy / Q000009:adverse effects / Q000592:standards*; D061665:Time-to-Treatment / Q000592:standards; D010959:Tissue Plasminogen Activator / Q000008:administration & dosage / Q000009:adverse effects / Q000592:standards*; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000959:Antihypertensive Agents; D005343:Fibrinolytic Agents; D010959:Tissue Plasminogen Activator
keywords: Acute ischemic stroke; patient safety; protocol violation; symptomatic intracerebral hemorrhage; thrombolysis
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