Published Online
on March 20, 2003

A more recent version of this article appeared on April 1, 2003

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Submitted on November 1, 2002
Accepted on November 5, 2002

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; and 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.

^* To whom correspondence should be addressed. 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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