rtPA 同意書

Informing patients about the risks of intravenous tissue plasminogen activator therapy


The main risk of tissue plasminogen activator (tPA) therapy for stroke is intracranial hemorrhage. In the National Institute of Neurological Disorders and Stroke rt-PA Stroke Trial (1), the risk of symptomatic intracranial hemorrhage was 6.4% in patients who received tPA and 0.6% in those who received placebo. Hemorrhage was associated with more severe strokes, evidence of infarction on the pretreatment computed tomography scan, and uncontrolled hypertension. Despite the increased risk of bleeding, overall mortality at 3 months was not significantly higher in the treatment group than in the placebo group. In addition, patients treated with tPA were at least 30% more likely to have minimal or no disability at 3 months.


After a stroke, a patient's ability to fully comprehend the risks and benefits of tPA therapy may be compromised by apprehension, aphasia, visuospatial neglect, or altered consciousness. In addition, a 3-hour therapeutic window leaves little time to counsel patients before initiating therapy. Therefore, when talking with patients and their families, physicians need to be direct and should invite questions. When describing the physiologic rationale for treatment, it is helpful to use simple words and phrases (eg, "bleeding" rather than "hemorrhage," "inside the head" rather than "intracranial"). Levels of risk should be described in whole numbers or simple fractions rather than decimals. When the patient has been informed of the risks and agrees to proceed with tPA therapy, receipt of verbal consent should be documented in his or her medical record.