OBJECT: Cerebral artery vasospasm is a major cause of death and disability in patients recovering from subarachnoid hemorrhage (SAH). Although the exact cause of vasospasm is unknown, one body of research suggests that clearing blood products by CSF drainage is associated with a lower frequency and severity of vasospasm. There are multiple approaches to facilitating CSF drainage, but there is inadequate evidence to determine the best practice. The purpose of this study was to explore whether continuous or intermittent CSF drainage was superior for reducing vasospasm. METHODS: The authors performed a randomized clinical trial. Within 72 hours of admission for SAH, patients with an external ventricular drain (EVD) were randomized to undergo continuous CSF drainage with intermittent intracranial pressure (ICP) monitoring (open-EVD group) or continuous ICP monitoring with intermittent CSF drainage (monitor-ICP group). RESULTS: After 60 patients completed the study, an interim analysis was performed. The complication rate of 52.9% for the open-EVD group was significantly higher than the 23.1% complication rate for the monitor-ICP group (OR 3.75, 95% CI 1.21-11.66, p = 0.022). These results were reported to the Data Safety and Monitoring Board and enrollment was terminated. The odds ratio of vasospasm for the open-EVD versus monitor-ICP group was not significant (OR 0.44, 95% CI 0.13-1.45, p = 0.177). CONCLUSIONS: Continuous CSF drainage with intermittent ICP monitoring is associated with a higher rate of complications than continuous ICP monitoring with intermittent CSF drainage, but there is no difference between the two types of monitoring in vasospasm. Clinical trial registration no.: NCT01169454 (clinicaltrials.gov).
RCT Entities:
OBJECT: Cerebral artery vasospasm is a major cause of death and disability in patients recovering from subarachnoid hemorrhage (SAH). Although the exact cause of vasospasm is unknown, one body of research suggests that clearing blood products by CSF drainage is associated with a lower frequency and severity of vasospasm. There are multiple approaches to facilitating CSF drainage, but there is inadequate evidence to determine the best practice. The purpose of this study was to explore whether continuous or intermittent CSF drainage was superior for reducing vasospasm. METHODS: The authors performed a randomized clinical trial. Within 72 hours of admission for SAH, patients with an external ventricular drain (EVD) were randomized to undergo continuous CSF drainage with intermittent intracranial pressure (ICP) monitoring (open-EVD group) or continuous ICP monitoring with intermittent CSF drainage (monitor-ICP group). RESULTS: After 60 patients completed the study, an interim analysis was performed. The complication rate of 52.9% for the open-EVD group was significantly higher than the 23.1% complication rate for the monitor-ICP group (OR 3.75, 95% CI 1.21-11.66, p = 0.022). These results were reported to the Data Safety and Monitoring Board and enrollment was terminated. The odds ratio of vasospasm for the open-EVD versus monitor-ICP group was not significant (OR 0.44, 95% CI 0.13-1.45, p = 0.177). CONCLUSIONS: Continuous CSF drainage with intermittent ICP monitoring is associated with a higher rate of complications than continuous ICP monitoring with intermittent CSF drainage, but there is no difference between the two types of monitoring in vasospasm. Clinical trial registration no.: NCT01169454 (clinicaltrials.gov).
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