Trial Procedures
vasospasm, aneurysm, angioplasty
ANEURYSM, VASOSPASM, STERILE, SUBARACHNOID HEMORRHAGE, EMERGENCY
Emergency treatment on admission using intubation and/or placement of an external ventricular drain was at the discretion of the local team. We performed aneurysm treatment with coiling or clipping, as applicable and per local standard and in concordance with international guidelines and recommendations.In case of randomization to the lumbar drain group, a lumbar drain was placed in sterile technique after aneurysm treatment. Lumbar cerebrospinal fluid diversion was started after a postprocedural CT scan indicated safety. A rate of 5 mL per hour was recommended for the first 8 days. Protocol-compliant treatment required at least 4 days, resulting in an equivalent of 480 mL of lumbar cerebrospinal fluid drainage for per-protocol analysis. Additional diversion via external ventricular drainage was at the discretion of the local team. Intracranial pressure (ICP) monitoring was performed as per local standard. Zeroing of both ventricular and lumbar drains was similar on the level of the external acoustic channel. This facilitated a valid ICP reading of all drains and allowed to recognize a developing craniocaudal gradient as indication for excess lumbar drainage.Daily transcranial Doppler monitoring was performed as per local standard. In case of suspected vasospasm or routinely on day 7 to 10 after the initial subarachnoid hemorrhage, vascular imaging either via CT angiography, magnetic resonance angiography, or conventional digital subtraction angiography was scheduled. Treatment of confirmed vasospasm could include balloon angioplasty or local intra-arterial vasodilators, with application being at the discretion of the local investigators and not specified in the EARLYDRAIN trial protocol. Due to the interventional character of the trial, blinding of acute caregivers, except local radiologists, was not possible.