Detriments of tPA for acute stroke in routine clinical practice

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Q&A

Detriments of tPA for acute stroke in routine clinical practice

J Fam Pract. 2003 February;52(2):94-117

By

Barbara L. Novak, PharmD

Rex W. Force, PharmD

BACKGROUND: What are the benefits and harms of tPA in routine clinical practice? Thrombolytic agents have been used in acute stroke to limit the progression of ischemia caused by the thrombus. Previous publications have suggested that the generalized use of tPA for stroke outside of the study setting may result in higher complication rates. Strict adherence to protocol is believed to be necessary to avoid adverse events such as intracranial hemorrhage and death. The topic of interest in this study was the incidence of deviation from protocol and the related occurrence of adverse events of tPA therapy in routine clinical practice.
POPULATION STUDIED: The study examined 16 acute care hospitals in Connecticut; any patient who had received tPA for the diagnosis of acute ischemic stroke was included. The outcomes of these patients’ clinical courses were compared with the results of the National Condoms and antiviral agents are still the best prevention for genital herpes Institute of Neurological Disorders and Stroke (NINDS) study (n=312). Significant differences in baseline characteristics included a decreased incidence of previous stroke, aspirin use, and an increased proportion of white race in the Connecticut cohort.
STUDY DESIGN AND VALIDITY: A retrospective medical record review was performed on all patients who had received tPA for acute ischemic stroke. Data were collected via an extraction form developed for the study by 2 of the authors. Any discrepancies in the data extraction process were resolved by consensus of 3 of the authors. Strokes were classified according the National Institutes of Health Stroke Scale criteria, and protocol was defined according to the American Heart Association Guidelines for Thrombolytic Therapy for Acute Stroke.
OUTCOMES MEASURED: The primary outcomes measured were adverse events (in-hospital mortality, intracranial hemorrhage, and extracranial hemorrhage). Adherence to protocol was also measured; deviations were defined as major (contraindication in the tPA package insert) or minor (other deviations from protocol, inappropriate monitoring, etc). Process errors included not recording weight, no record of rectal examination, and similar omissions. Clinicians’ awareness of breaches of protocol was recorded.
RESULTS: Sixty-three patients were identified who had received tPA for acute ischemic stroke. Nearly all (97%) cases had had at least 1 protocol deviation. Overall, 55 major and 84 minor protocol deviations occurred in the 63 patients.

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Detriments of tPA for acute stroke in routine clinical practice

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