Factors related to intracranial hematoma formation in patients receiving tissue-type plasminogen activator for acute ischemic stroke

David E. Levy, Thomas G. Brott, E. Clarke Haley, John R. Marler, George L. Sheppard, William Barsan, Joseph P. Broderick

Research output: Contribution to journalArticlepeer-review

180 Scopus citations


Background and PurposeSeveral 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. MethodsNinety-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. ResultsFactors 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. ConclusionsSince 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 throm-bolytic agents in stroke. (Stroke. 1994;25:291-297.).

Original languageEnglish (US)
Pages (from-to)291-297
Number of pages7
Issue number2
StatePublished - Feb 1994


  • Cerebrovascular disorders
  • Clinical trials
  • Hemorrhage
  • Plasminogen activator
  • Thrombolytic therapy
  • Tissue-type

ASJC Scopus subject areas

  • Clinical Neurology
  • Cardiology and Cardiovascular Medicine
  • Advanced and Specialized Nursing


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