Abstract
AsbtractBackgroundThere are limited neuroprotective treatment options for patients with aneurysmal subarachnoid hemorrhage (SAH). Cerebrolysin, a brain-specific proposed pleiotropic neuroprotective agent, has been suggested to improve global functional outcomes in ischemic stroke. We investigated the efficacy, safety and feasibility of administering Cerebrolysin for SAH patients.MethodsThis was a prospective, randomized, double-blind, placebo-controlled, single-center, parallel-group pilot study. Fifty patients received either daily Cerebrolysin (30 ml/day) or a placebo (saline) for 14 days (25 patients per study group). The primary endpoint was a favorable Extended Glasgow Outcome Scale (GOSE) of 5 to 8 (moderate disability to good recovery) at six-months. Secondary endpoints included the modified Ranking Scale (mRS), the Montreal Cognitive Assessment (MOCA) score, occurrence of adverse effects and the occurrence of delayed cerebral ischemia (DCI).ResultsNo severe adverse effects or mortality attributable to Cerebrolysin were observed. No significant difference was detected in the proportion of patients with favorable six-month GOSE in either study group (odds ratio (OR): 1.49; 95% confidence interval (CI): 0.43–5.17). Secondary functional outcome measures for favorable six-month recovery i.e. a mRS of 0 to 3 (OR: 3.45; 95% CI 0.79–15.01) were comparable for both groups. Similarly, there was no difference in MOCA neurocognitive performance (p-value: 0.75) and in the incidence of DCI (OR: 0.85 95% CI: 0.28–2.59).ConclusionsUse of Cerebrolysin in addition to standard-of-care management of aneurysmal SAH is safe, well tolerated and feasible. However, the neutral results of this trial suggest that it does not improve the six-month global functional performance of patients.Clinical trial registrationName of Registry: ClinicalTrials.govTrial Registration Number: NCT01787123.Date of Registration: 8th February 2013.
Highlights
There are limited neuroprotective treatment options for patients with aneurysmal subarachnoid hemorrhage (SAH)
No significant difference was detected in the proportion of patients with favorable six-month Glasgow Outcome Scale (GOSE) in either study group (odds ratio (OR): 1.49; 95% confidence interval (CI): 0.43–5.17)
Secondary functional outcome measures for favorable six-month recovery i.e. a modified Ranking Scale (mRS) of 0 to 3 (OR: 3.45; 95% CI 0.79–15.01) were comparable for both groups
Summary
There are limited neuroprotective treatment options for patients with aneurysmal subarachnoid hemorrhage (SAH). DCI is a major determinant of mortality, accounting for up to 50% of all SAHrelated deaths, and morbidity in patients that survive the initial hemorrhage [5, 6]. It occurs in 20–40% of patients, but in spite of its recognition as an important complication of SAH, its exact pathophysiology remains to be elucidated [7, 8]. Since it usually occurs between four and 10 days after SAH, there exists a potential therapeutic window that has been subject to substantial neuroprotective agent research [5]. The only consistently proven neuroprotective treatment for SAH that reduces poor clinical outcomes is nimodipine, a L-type calcium channel blocker that was discovered more than three decades ago [2, 17]
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