FACTORS RELATED TO INTRACRANIAL HEMATOMA FORMATION IN PATIENTS RECEIVING TISSUE-TYPE PLASMINOGEN-ACTIVATOR FOR ACUTE ISCHEMIC STROKE

Background and Purpose Several studies are currently evaluating tissue -type plasminogen activator (TPA) as a potential therapy in acute isch emic stroke. The possibility of inducing intracranial hematomas, howev er, introduces an important concern into ultimate evaluation of risk a nd benefit. This retrospective analysis sought to identify factors ass ociated 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 pa tients treated within 90 minutes of stroke onset and 2 of 20 (10%) amo ng those treated at 91 to 180 minutes. Three of the 5 died within 2 we eks. The analysis investigated associations between clinical factors a nd intracerebral hematomas. Results Factors significantly related to t he development of an intracerebral hematoma were TPA dose and diastoli c hypertension. Intracerebral hematomas developed in 4 (18%) of 22 pat ients given a TPA dose of at least 0.90 mg/kg versus only 1 hematoma i n the remaining 72 patients (1%; P<.02, Fisher's exact test). Four (18 %) of 22 patients who had initial diastolic blood pressures of at leas t 100 mm Hg suffered an intracerebral hematoma versus only 1 (1%) of 7 2 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 s tudies of thrombolytic agents in stroke.