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      Frequency and Predictors of Symptomatic Intracerebral Hemorrhage in Patients with Ischemic Stroke Treated with Recombinant Tissue Plasminogen Activator outside Clinical Trials

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          Background: To determine the frequency and predictors of symptomatic intracerebral hemorrhage (SICH) in patients treated with recombinant tissue plasminogen activator (rt-PA). Methods: We reviewed the databases of 7 tertiary hospitals that treated ischemic stroke patients with intravenous rt-PA. We recorded demographic data, vascular risk factors, time between onset and treatment, dose, the NIHSS score, body temperature, blood pressure, platelet count, blood glucose, antiplatelet treatment, and CT data. We also registered the study protocol used for treatment and deviations from the accepted protocol. A control CT was performed on all patients. SICH was diagnosed if a parenchymal hematoma was detected within the 36 h after rt-PA and was associated with an increase of ≧4 in the NIHSS score. Bivariate analyses were performed followed by a logistic regression analysis. Results: A total of 347 patients were studied, whose mean age was 68 ± 10.9 years; 56% were men. Thirty-two patients (9.2%) exhibited a parenchymal hematoma, and 8 patients (2.3%) suffered a SICH. Patients with SICH had a higher frequency of previous transient ischemic attack (p = 0.04), early signs of ischemia (p = 0.003), hyperdense arterial sign (p = 0.008), and deviations (p = 0.002). Early signs of ischemia (OR 8.5, 95% CI 1.6–45.4, p = 0.01) and deviation from the protocol (OR 11.1, 95% CI 2.4–50, p = 0.002) were independent predictors of SICH. Conclusions: SICH is infrequent in patients with ischemic stroke treated with rt-PA outside of a clinical trial. Its frequency increases in the presence of early signs of ischemia on the noncontrast CT scan and deviations from the recommended protocol.

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          Most cited references 16

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          Recombinant Tissue-Type Plasminogen Activator (Alteplase) for Ischemic Stroke 3 to 5 Hours After Symptom Onset

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            Tissue plasminogen activator for acute ischemic stroke in clinical practice: a meta-analysis of safety data.

             Garry Graham (2003)
            Concerns persist regarding the safety of tissue plasminogen activator (tPA) therapy for acute ischemic stroke. Numerous case series of clinical experience with tPA have been published that provide additional data on the safety of thrombolytic therapy. This is a meta-analysis of 15 published, open-label studies that broadly followed approved indications and guidelines for tPA use in nonselective patient populations. In 2639 treated patients, the symptomatic intracerebral hemorrhage rate was 5.2% (95% confidence interval, 4.3 to 6.0), slightly lower than the 6.4% rate in the treated group of the randomized, placebo-controlled National Institute of Neurological Disorders and Stroke (NINDS) trial. The mean total death rate (13.4%) and proportion of subjects achieving a very favorable outcome (37.1%) were comparable to the NINDS trial results. Protocol deviations were reported in 19.8%. Comparing across studies showed that the mortality rate was correlated with the percentage of protocol violations (r=0.67, P=0.018). Postapproval data support the safety of intravenous thrombolytic therapy with tPA for acute ischemic stroke, especially when established treatment guidelines are followed.
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              Use of Tissue-Type Plasminogen Activator for Acute Ischemic Stroke


                Author and article information

                Cerebrovasc Dis
                Cerebrovascular Diseases
                S. Karger AG
                February 2007
                15 November 2006
                : 23
                : 2-3
                : 85-90
                Departments of aNeurology, bNeuroradiology and cInternal Medicine, Hospital de la Santa Creu i Sant Pau, Barcelona, and Departments of Neurology, dHospital Universitario Santiago de Compostela, Santiago de Compostela, eHospital Universitari Dr. Josep Trueta, Girona, fHospital Universitari Germans Trias i Pujol, Badalona, gHospital del Mar, hHospital Clínic Barcelona, Barcelona, and iHospital Virgen de las Nieves, Granada, Spain
                97043 Cerebrovasc Dis 2007;23:85–90
                © 2007 S. Karger AG, Basel

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                Page count
                Figures: 1, Tables: 2, References: 31, Pages: 6
                Original Paper


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