Baseline Characteristics of Patients Recruited for the EARLYDRAIN trial (Intention-To-Treat Data)
aneurysm, fever, Aneurysm, vasospasm, subarachnoid hemorrhage
ANEURYSM, SUBARACHNOID HEMORRHAGE, VASOSPASM, ANEURYSM
Abbreviations: ACA, anterior cerebral artery; ACoA, anterior communicating artery; BA, basilar artery; ICA, internal carotid artery; MCA, middle cerebral artery; PCoA, posterior communicating artery; VA, vertebral artery; WFNS, World Federations of Neurosurgical Societies.Hunt-Hess and WFNS (World Federations of Neurosurgical Societies) scales are severity gradings scales, with 1 indicating the least severe and 5 indicating the worst neurological status on admission.The modified Fisher classification is a radiological grading scale of subarachnoid hemorrhage severity ranging from 1 to 4, with higher scores indicating more severity.Aneurysm size not available in 8 patients.In the lumbar drain group, 109 patients (75.7%) received a lumbar drain after aneurysm treatment with drainage as specified. A total of 141 patients (98.6%) in the standard of care group were treated according to protocol; 2 (1.4%) received high-volume lumbar drainage as specified for the lumbar drain group. All crossover patients were kept in the intention-to-treat analysis in their randomized groups, independent of actual treatment. This results in a conservative estimation of effect size. Patients from both groups with drainage as specified were looked at in the per-protocol sensitivity analysis, while actual treatment was investigated in the as-treated analysis, with a threshold of 480-mL lumbar drainage in the first 8 days to separate between groups. Reasons for crossover from both groups, as far as known, can be found in eAppendix 1 in Patients in the lumbar drain group received a median (IQR) daily lumbar drainage of 108 (92-118) mL in the first 8 days. A total of 102 patients (70.8%) in the lumbar drain group and 110 patients (76.9%) in the standard of care group had an external ventricular drain installed. Median (IQR) daily fluid drainage via ventricular drain was lower in the lumbar drain group (98 [60-150] mL vs 171 [110-225] mL; Patients in the lumbar drain group showed a lower ICP. No differences were noted in mean daily arterial pressure, fever burden, transcranial Doppler, hemoglobin levels, fluid intake, and fluid balance (eFigures 3-13 in No differences between the lumbar drain group and standard of care group were observed in the frequency of vasospasm diagnosed clinically (41 [28.5%] vs 48 [33.6%]; 