Article
A multimodal approach to cerebral vasospasm in patients after severe aneurysmal subarachnoid hemorrhage: Results of a controlled single centre prospective randomized phase 1 trial
Ein multimodal therapeutischer Ansatz in der Prophylaxe des zerebralen Vasospasmus nach aneurysmatischer Subarachnoidalblutung: Erste Resultate einer monozentrischen prospektiv randomisierten Phase-I-Studie
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Authors
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D. Hänggi
- Neurochirurgische Klinik, Heinrich-Heine-Universität, Düsseldorf
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S. Eicker
- Neurochirurgische Klinik, Heinrich-Heine-Universität, Düsseldorf
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K. Beseoglu
- Neurochirurgische Klinik, Heinrich-Heine-Universität, Düsseldorf
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J. Behr
- Neurochirurgische Klinik, Heinrich-Heine-Universität, Düsseldorf
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H.-J. Steiger
- Neurochirurgische Klinik, Heinrich-Heine-Universität, Düsseldorf
| Published: | May 30, 2008 |
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Outline
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Objective: Recent publications suggested that a combination of head-shaking and cisternal irrigation might reduce cerebral vasospasm after subarachnoid hemorrhage (SAH). Furthermore the concept of local therapy provides promising results. The current clinical prospective randomized phase 1 study was initiated in order to analyze the effect of intracisternal lysis in combination with kinetic treatment followed by intrathecal nimodipine lavage on cerebral vasospasm and clinical outcome.
Methods: Twenty patients with aneurysmal SAH, WFNS grade 2 to 5 (GCS 13-3) and Fisher grade 3 or 4 were included in this prospective randomized study, approved by the local ethics committee. Following insertion of a ventricular drain, securing the aneurysm and insertion of two lumbar catheters, intracisternal lysis with urokinase 120.000 IU/d was performed for 48 h for patients elected to the study group. Intrathecal pressure was monitored by the second lumbar catheter. After intracisternal lysis intrathecal nimodipine lavage was applied for 7 days. For comatose patients moderate head-rotation was performed additionally. Vasospasm was identified clinically with focus on delayed neurological deficits (DIND’s), daily transcranial Doppler (TCD), computerized tomography (CT), perfusion CT measurements and cerebral angiography (DSA).
Results: Among the awake patients there was no DIND in the study group compared with 2 DIND in the control group. The pooled TCD flow velocities over an average period of 14 days revealed no statistically significant differences between the groups. Vasospasm-related infarction on CT was seen in two patients of the control group. Evident vasospasm on DSA appeared in three patients of the study group compared with 7 patients in the control group. A clinical advantage of the study group was apparent at the time of discharge and at 3 months after therapy. Two patients in the study group developed paresis of lower extremities of unknown origin.
Conclusions: The multimodal approach with intracisternal lysis in combination with kinetic therapy followed by intrathecal nimodipine lavage demonstrated its effectiveness on cerebral vasospasm and clinical outcome. Nevertheless, patients belonging to the study group demonstrated unclear side effects which must be carefully observed in the further phase II trial.
