At a glance
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EARLYdrain - Prospective Outcome Study of Early Lumbar Drainage in Aneurysmal Subarachnoid Hemorrhage
In Brief
A Phase 3 clinical trial evaluating Insertion of a lumbar drain for Aneurysmal Subarachnoid Hemorrhage. Completed, enrolled 300 participants across 1 site.
Detailed Summary
The intention of the study is to investigate whether drainage of cerebral spinal fluid via a lumbar route ("Tuohy-drain") will improve outcome after intracranial aneurysmal subarachnoid hemorrhage (SAH).
Study Details
Timeline
Interventions
In patients in the LD group, after insertion of the drain CSF is drained slowly and steadily at a rate of approximately 5 ml per hour. This leads to a planned daily CSF drainage of about 120 ml per day via lumbar route. To facilitate accuracy of drainage, regular drainage control every other hour and stopping in case of unwarranted excess drainage is strongly recommended by the principal investigators. In case of neurological decline suspiciously related to the lumbar drainage, the drain is closed immediately and may be gradually restarted after 12 to 24 hours, after performing a CCT scan. The drain is planned to remain in place until the control angiography on day 7 to 10 after the initial hemorrhage.