Abstract W P233: Multi-Center Study of Adverse Events After Tissue-Type Plasminogen Activator Treatment for Ischemic Stroke

Abstract

RESEARCH QUESTION: When do adverse events occur within 24 hours after intravenous tissue-type plasminogen activator (IV tPA) treatment for acute stroke? BACKGROUND AND PURPOSE: The FDA approved medication for ischemic stroke is IV tPA. Patients are monitored for adverse events using a protocol that has been in use since 1995. There is limited evidence for the safest and most efficient monitoring protocol. The purpose of this study was to identify when adverse events occur within 24 hours post IV tPA. METHODS: This was a retrospective descriptive study. A convenience sample of medical records of 597 patients was examined using a pharmacy adverse event report, a computerized abnormal vital sign detection program, and a manual data collection tool. Detecting indicators of potential adverse events was used to identify high-risk patients for manual data collection. Indicators included heart rate above 120 bpm and systolic blood pressure (SBP) < 90 mm Hg and >180 mm Hg. The high-risk patient group (n=420) was randomly sampled. Then episodes of neurological decline, allergic reactions, and intracerebral hemorrhage (ICH) were manually collected on 220 patients. The time the event was detected was determined. A scoring system was used to identify the degree of risk in the ICH events. Statistical analysis was done using descriptive statistics. RESULTS: A total of 597 patients received IV tPA for ischemic stroke, of which 420 patients (70.3%) were found to have an abnormal vital sign trigger. Eighty percent of vital sign abnormalities and episodes of neurological decline occurred within the first twelve hours of IV tPA administration. Ten (4.5%) adverse events were detected. They were allergic reaction (1.8%; n=4) and high-risk ICH (2.7%; n=6). All adverse events occurred within the first 12 hours of IV tPA administration. CONCLUSION: Close monitoring during the first 12 hours after IV tPA treatment may be essential for safety. However, ICU or step down monitoring after 12 hours may not significantly impact outcome. Larger studies may provide evidence for the safest monitoring for patients treated with IV tPA for ischemic stroke.