Stroke, Vol 25, 291-297, Copyright © 1994 by American Heart Association
DE Levy, TG Brott, EC Haley Jr, JR Marler, GL Sheppard, W Barsan and JP Broderick
BACKGROUND AND PURPOSE: Several studies are currently evaluating tissue-
type plasminogen activator (TPA) as a potential therapy in acute ischemic
stroke. The possibility of inducing intracranial hematomas, however,
introduces an important concern into ultimate evaluation of risk and
benefit. This retrospective analysis sought to identify factors associated
with intracranial hematoma formation in a pilot phase 1 study of TPA for
stroke. METHODS: Ninety-four patients received TPA within 3 hours of the
onset of an acute ischemic stroke. Five of these patients developed a
symptomatic intracerebral hematoma: 3 of 74 (4%) among patients treated
within 90 minutes of stroke onset and 2 of 20 (10%) among those treated at
91 to 180 minutes. Three of the 5 died within 2 weeks. The analysis
investigated associations between clinical factors and intracerebral
hematomas. RESULTS: Factors significantly related to the development of an
intracerebral hematoma were TPA dose and diastolic hypertension.
Intracerebral hematomas developed in 4 (18%) of 22 patients given a TPA
dose of at least 0.90 mg/kg versus only 1 hematoma in the remaining 72
patients (1%; P < .02, Fisher's exact test). Four (18%) of 22 patients
who had initial diastolic blood pressures of at least 100 mm Hg suffered an
intracerebral hematoma versus only 1 (1%) of 72 patients (P < .02) with
lower initial diastolic pressures. CONCLUSIONS: Since the study was not
designed to test specific safety hypotheses, results must not be
overinterpreted. Nonetheless, these data emphasize the need for caution in
both patient and dose selection for further studies of thrombolytic agents
in stroke.
ARTICLES
Factors related to intracranial hematoma formation in patients receiving tissue-type plasminogen activator for acute ischemic stroke
Department of Neurology, Cornell University Medical College, New York, NY.
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