Safety of protocol violations in acute stroke tPA administration

Michael J. Lyerly, Karen C. Albright, Amelia K. Boehme, Reza Bavarsad Shahripour, James T. Houston, Pawan Rawal, Niren Kapoor, Muhammad Alvi, April Sisson, Anne Alexandrov, Andrei Alexandrov

Research output: Contribution to journalArticle

13 Citations (Scopus)

Abstract

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.

Original languageEnglish (US)
Pages (from-to)855-860
Number of pages6
JournalJournal of Stroke and Cerebrovascular Diseases
Volume23
Issue number5
DOIs
StatePublished - Jan 1 2014

Fingerprint

Stroke
Safety
Cerebral Hemorrhage
National Institute of Neurological Disorders and Stroke
Hemorrhage
Partial Thromboplastin Time
Prothrombin Time
National Institutes of Health (U.S.)
Tissue Plasminogen Activator
Registries
Therapeutics
Odds Ratio
Confidence Intervals
Blood Pressure
Physicians
Glucose

All Science Journal Classification (ASJC) codes

  • Surgery
  • Rehabilitation
  • Clinical Neurology
  • Cardiology and Cardiovascular Medicine

Cite this

Safety of protocol violations in acute stroke tPA administration. / Lyerly, Michael J.; Albright, Karen C.; Boehme, Amelia K.; Bavarsad Shahripour, Reza; Houston, James T.; Rawal, Pawan; Kapoor, Niren; Alvi, Muhammad; Sisson, April; Alexandrov, Anne; Alexandrov, Andrei.

In: Journal of Stroke and Cerebrovascular Diseases, Vol. 23, No. 5, 01.01.2014, p. 855-860.

Research output: Contribution to journalArticle

Lyerly, MJ, Albright, KC, Boehme, AK, Bavarsad Shahripour, R, Houston, JT, Rawal, P, Kapoor, N, Alvi, M, Sisson, A, Alexandrov, A & Alexandrov, A 2014, 'Safety of protocol violations in acute stroke tPA administration', Journal of Stroke and Cerebrovascular Diseases, vol. 23, no. 5, pp. 855-860. https://doi.org/10.1016/j.jstrokecerebrovasdis.2013.07.019
Lyerly, Michael J. ; Albright, Karen C. ; Boehme, Amelia K. ; Bavarsad Shahripour, Reza ; Houston, James T. ; Rawal, Pawan ; Kapoor, Niren ; Alvi, Muhammad ; Sisson, April ; Alexandrov, Anne ; Alexandrov, Andrei. / Safety of protocol violations in acute stroke tPA administration. In: Journal of Stroke and Cerebrovascular Diseases. 2014 ; Vol. 23, No. 5. pp. 855-860.
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