Stereotactic treatment of intracerebral hematoma by means of a plasminogen activator: a multicenter randomized controlled trial (SICHPA).
OBJECTIVE
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.
Teernstra
O P M
OP
Department of Neurosurgery, University Hospital Maastricht, The Netherlands. ote@snch.azm.nl
Evers
S M A A
SM
Lodder
J
J
Leffers
P
P
Franke
C L
CL
Blaauw
G
G
D000368:Aged; D002404:Catheterization; D002543:Cerebral Hemorrhage / Q000188:drug therapy / Q000401:mortality / Q000601:surgery / Q000628:therapy*; D003131:Combined Modality Therapy; D005260:Female; D006406:Hematoma / Q000188:drug therapy / Q000401:mortality / Q000601:surgery / Q000628:therapy*; D006801:Humans; D001239:Inhalation; D008297:Male; D008875:Middle Aged; D010960:Plasminogen Activators / Q000627:therapeutic use*; D013238:Stereotaxic Techniques; D015912:Thrombolytic Therapy
D010960:Plasminogen Activators