Published Online
on August 23, 2007

A more recent version of this article appeared on October 1, 2007

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Submitted on January 9, 2007
Revised on March 19, 2007
Accepted on April 12, 2007

Bleeding Risk Analysis in Stroke Imaging Before ThromboLysis (BRASIL). Pooled Analysis of T2*-Weighted Magnetic Resonance Imaging Data From 570 Patients

Jens Fiehler MD^*; Gregory W. Albers MD; Jean-Martin Boulanger MD; Laurent Derex MD; Achim Gass MD; Niels Hjort MD; Jong S. Kim MD; David S. Liebeskind MD; Tobias Neumann-Haefelin MD; Salvador Pedraza MD; Joachim Rother MD; Peter Rothwell MD, PhD; Alex Rovira MD; Peter D. Schellinger MD; Johannes Trenkler MD; for the MR STROKE Group

From the Department of Neuroradiology (J.F.), University Medical Centre, Hamburg, Germany; Stanford Stroke Center (G.W.A.), Palo Alto, Calif; Seaman Family MR Research Centre (J.-M.B.), Foothills Medical Centre, Calgary, Canada; Hôpital Neurologique (L.D.), Laboratoire CREATIS UMR 5515 CNRS and INSERM U 630, Hôpital Neurologique, Lyon, France; Neurologische Klinik (A.G.), Universitaetsklinikum Mannheim, Mannheim, Germany; Center for Functionally Integrative Neuroscience (N.H.), Department of Neuroradiology, Aarhus University Hospital, Aarhus, Denmark; Asan Medical Centre (J.S.K.), Seoul, Korea; UCLA Stroke Center (D.S.L.), University of California, Los Angeles, Calif; Department of Neurology (T.N.-H.), Institute of Neuroradiology, University Hospital, Frankfurt, Germany; Departments of Radiology and Neurology (S.P.), University Hospital, Girona, Spain; Neurologische Klinik (J.R.), Klinikum Minden, Minden, Germany; Stroke Prevention Research Unit (P.R.), Department of Clinical Neurology, University of Oxford, Oxford, England; MR Unit (A.R.), Department of Radiology, Institution Hospital Universitari Vall d’Hebron, Barcelona, Spain; Neurologische Klinik, Universitaetsklinikum Heidelberg, Kopfklinik, Heidelberg, and Neurologische Klinik, Universitaetsklinikum Erlangen (P.D.S.), Erlangen, Germany; and Institut für Radiologie (J.T.), Klinik für Neurologie, Landes-Nervenklinik Wagner-Jauregg, Linz, Austria.

^* To whom correspondence should be addressed. E-mail: fiehler{at}uke.uni-hamburg.de.

Background and Purpose—There has been speculation that the risk of secondary symptomatic intracranial hemorrhage (SICH) may be increased after thrombolytic therapy in ischemic stroke patients who have cerebral microbleeds (CMBs) on T2*-weighted magnetic resonance imaging. Because of this concern, some centers withhold potentially beneficial thrombolytic therapy from these patients.

Methods—We analyzed magnetic resonance imaging data acquired within 6 hours after symptom onset from 570 ischemic stroke patients treated with intravenous tissue plasminogen activator in 13 centers in Europe, North America, and Asia. Baseline T2*-weighted magnetic resonance images were evaluated for the presence of CMBs. The primary end point was SICH, defined as clinical deterioration with an increase in the National Institutes of Health Stroke Scale score by 4 points, temporally related to a parenchymal hematoma on follow-up-imaging.

Results—A total of 242 CMBs were detected in 86 of 570 patients (15.1%). The number of CMBs ranged from 1 to 77 in the individual patient, with 5 CMBs in 6 of 570 patients (1.1%). Proportions of patients with SICH were 5.8% (95% CI, 1.9 to 13.0) in the presence of CMBs and 2.7% (95% CI, 1.4 to 4.5) in patients without CMBs (P=0.170, Fisher’s exact test), resulting in no significant absolute increase in the risk of SICH of 3.1% (95% CI, -2.0 to 8.3).

Conclusions—The data suggest that if there is any increased risk of SICH attributable to CMBs, it is likely to be small and unlikely to exceed the benefits of thrombolytic therapy. No reliable conclusion regarding risk in the rare patient with multiple CMBs can be reached.

Key words: hemorrhage, intracranial • stroke • stroke management • therapy • thrombolysis

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