At 6 months, a larger proportion of patients on standard of care experienced unfavorable outcomes, as demonstrated by modified Rankin Scale scores greater than 3, in comparison with lumbar drainage.
A recently published study (NCT01258247) in JAMA Neurology showed that use of lumbar drains after aneurysmal subarachnoid hemorrhage may lessen the burden of secondary infarction and decrease the rate of unfavorable outcome relative to standard of care alone.
Otherwise known as the EARLYDRAIN trial patients were randomly assigned to receive an additional lumbar drain after aneurysm treatment (n = 144) or standard of care (n = 143), with early lumbar drainage ensuing within 72 hours after the hemorrhage. At 6 months, 32.6% (n = 47) of patients in the lumbar drain group and 44.8% (n = 64) in the standard of care group had an unfavorable neurological outcome, defined as modified Rankin Scale scores between 3 and 6 (risk ratio, 0.73; 95% CI, 0.52-0.98; P = .04).
Led by Stefan Wolf, MD, Department of Neurosurgery and Pediatric Neurosurgery, Charite Universitatsmedizin Berlin, the trial was open-label with blinded end point evaluation conducted at 19 centers across 3 countries. Patients included were at least 18 years of age and had confirmation of intracranial aneurysm by CT angiography or digital subtraction angiography. Aneurysm treatment, which included coiling or clipping, as applicable and in concordance with international guidelines and recommendations, was required to be performed within 48 hours after subarachnoid hemorrhage.
Between the groups, no differences were observed in the frequency of vasospasm diagnosed clinically (28.5% vs 33.6%; P = .35) via transcranial Doppler (26.9% vs 24.8%; P = .70) or with angiography (46.0% vs 44.0%; P = .77). Ten patients (6.9%) in the lumbar drain group and 14 patients (9.8%) in the standard of care group were treated with either balloon angioplasty or intra-arterial vasodilators as rescue therapy for vasospasm.
Even after adjusting for age, Hunt-Hess grade, and presence of intracerebral and intraventricular hemorrhage, the relative risk for unfavorable outcome was 0.76 (95% CI, 0.54-1; P = .047). In terms of secondary outcomes, cases of secondary infarction on the last cerebral imaging scan before discharge were found in 28.5% of the lumbar drain group and 39.9% of those on standard of care (unadjusted relative risk, 0.71; 95% CI, 0.49-0.99; absolute risk difference, –0.11; P = .04).
"The amount of cerebrospinal fluid drained in the first week was similar in the lumbar drain and standard of care groups,” Wolf et al wrote. "The color difference in fluid from a ventricular and a lumbar drain when both are used simultaneously is visually striking. In subarachnoid hemorrhage, the blood is predominantly in the basal cisterns and the ventricular system. Erythrocytes in cerebrospinal fluid tend to sediment by weight, rendering their removal by a lumbar drain more feasible than by an external ventricular drain."
Other secondary outcomes, which included death, showed that 19 patients (13.2%) in the lumbar drain group and 25 patients (17.5%) in the standard of care group died within 6 months (unadjusted relative risk, 0.75; 95% CI, 0.42-1.28; P =.31). There were no differences in the causes of death between groups, and no patients died because of complications related to the lumbar drain. Subgroup analyses, which split patients based on Hunt-Hess grade, WFNS grade, modified Fisher radiological grade, and many others, showed that lumbar drains remained effective regardless of specific patient subtype.
In terms of adverse events, 1 patient reported to develop an increasing gradient of more than 5 mm Hg in ICP readings from the external ventricular drain and the lumbar drain, prohibiting continuation of lumbar drainage. In multivariate analysis, the presence of an external ventricular drain was the only risk factor associated with the development of infection. In 1 patient, the lumbar drain was torn off, requiring surgical removal.