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(Stroke. 2003;34:968.)
© 2003 American Heart Association, Inc.

Original Contributions

Stereotactic Treatment of Intracerebral Hematoma by Means of a Plasminogen Activator

A Multicenter Randomized Controlled Trial (SICHPA)

O.P.M. Teernstra, MD; S.M.A.A. Evers, PhD; J. Lodder, MD; P. Leffers, MSc; C.L. Franke, MD G. Blaauw, MD

From the Departments of Neurosurgery (O.P.M.T., S.M.A.A.E., G.B.) and Neurology (J.L.), University Hospital Maastricht; Departments of Neurosurgery (O.P.M.T.) and Neurology (C.L.F.), Atrium Medical Center Heerlen; and Departments of Health Organization Policy and Economics (S.M.A.A.E.) and Epidemiology (P.L.), University of Maastricht, the Netherlands.

Correspondence to Dr Onno P. Teernstra, Department of Neurosurgery, University Hospital Maastricht, PB 5800, 6202 AZ, Maastricht, the Netherlands. E-mail ote{at}snch.azm.nl

Background and Purpose— Treatment of intracerebral hematoma (ICH) is controversial. An advantage of neurosurgical intervention over conservative treatment of ICH has not been established. Recent reports suggest a favorable effect of stereotactic blood clot removal after liquefaction by means of a plasminogen activator. The SICHPA trial was aimed at investigating the efficacy of this treatment.

Methods— A stereotactically placed catheter was used to instill urokinase to liquefy and drain the ICH in 6-hour intervals over 48 hours. From 1996 to 1999, 13 centers entered 71 patients into the study. Patients were randomized into a surgical group (n=36) and a nonsurgical group (n=35). Admission criteria were the following: age >45 years, spontaneous supratentorial ICH, Glasgow Eye Motor score ranging from 2 to 10, ICH volume >10 cm³, and treatment within 72 hours. The primary end point was death at 6 months. As secondary end points, ICH volume reduction and overall outcome measured by the modified Rankin scale were chosen. The trial was prematurely stopped as a result of slow patient accrual.

Results— Seventy patients were analyzed. Overall mortality at day 180 after stroke was 57%; this included 20 of 36 patients (56%) in the surgical group and 20 of 34 patients (59%) in the nonsurgical group. A significant ICH volume reduction was achieved by the intervention (10% to 20%, P<0.05). Logistic regression analysis indicated the possibility of efficacy for surgical treatment (odds ratio, 0.23; 95% confidence interval, 0.05 to 1.20; P=0.08). The odds ratio of mortality combined with modified Rankin scale score 5 at 180 days was also not statistically significant (odds ratio, 0.52; 95% confidence interval, 1.2 to 2.3; P=0.38).

Conclusions— Stereotactic aspiration can be performed safely and in a relatively uniform manner; it leads to a modest reduction of 18 mL of hematoma reduction over 7 days when compared with control, which has a 7-mL reduction, and therefore may improve prognosis.

Key Words: intracerebral hemorrhage • randomized controlled trials • stereotactic aspiration • surgical treatment • thrombolytic therapy

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