Article
Intraventricular thrombolysis in combination with continuous lateral rotational therapy after severe subarachnoid haemorrhage: results of a prospective randomized single center phase II study
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Authors
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J. Behr
- Neurochirurgische Klinik, Klinikum der Heinrich-Heine-Universität, Düsseldorf
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N. Etminan
- Neurochirurgische Klinik, Klinikum der Heinrich-Heine-Universität, Düsseldorf
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B. Turowski
- Institut für Radiologie, Klinikum der Heinrich-Heine-Universität Düsseldorf
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H.-J. Steiger
- Neurochirurgische Klinik, Klinikum der Heinrich-Heine-Universität, Düsseldorf
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D. Hänggi
- Neurochirurgische Klinik, Klinikum der Heinrich-Heine-Universität, Düsseldorf
| Published: | May 20, 2009 |
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Outline
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Objective: Recent publications suggested that a combination of intraventricular thrombolysis and head-shaking might reduce cerebral vasospasm after subarachnoid haemorrhage (SAH) and therefore improve outcome. The current clinical prospective randomized phase II study was initiated in order to analyze the effect of enhanced washout by intraventricular thrombolysis in combination with lateral rotational therapy on clot clearance rate, cerebral vasospasm and clinical outcome.
Methods: 20 adult patients with aneurismal SAH, WFNS grade 2 to 5 (GCS 13–3) and Fisher grade 3 or 4 were included in this study, approved by the local ethics committee. Study group and control group consisted of 10 patients each. In both groups patients were treated according to a standardized protocol. Additional for patients randomized to the study group, intraventricular application of rt-PA (Actilyse®) bolus 5 mg every 12 hours with a total amount of four applications and lateral rotational therapy (RotoRest®) for at least 48 hours was performed. Clot clearance rate was evaluated based computerized tomography (CT). Furthermore vasospasm was detected with focus on delayed neurological deficits (DIND), transcranial Doppler (TCD), perfusion CT (PCT) and cerebral angiography (DSA).
Results: There was no procedure related complication. The clot clearance rate in the study group was accelerated but results did not differ significantly. 1 patient in the study group compared with 4 patients in the control group developed a DIND. Vasospasm as detected by TCD and PCT demonstrated a statistically significant difference between both groups (p<0.05). The incidence of angiographic vasospasm was 3 in the study group and 7 in the control group. Ischemic areas on CT scan related to vasospasm were not demonstrated in the study group and in 3 patients of the control group. Clinical outcome at discharge demonstrated a better neurological condition in the treatment group measured by the modified Rankin scale (mRS) and Glasgow Outcome Score (GOS).
Conclusions: The present phase II study demonstrates that a combination of intraventricular thrombolysis and lateral rotational therapy leads to a reduction of the incidence of DIND, the vasospasm detected on TCD and PCT as well as on DSA probably due to an observed acceleration of clot clearance rate in patients after severe aneurismal SAH. No procedure-related complications were observed so that an inclusion of further patients in a phase III study is important.
