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Clinical Trial
. 2020 Nov 3;20(1):401.
doi: 10.1186/s12883-020-01908-9.

Randomized, placebo-controlled, double-blind, pilot trial to investigate safety and efficacy of Cerebrolysin in patients with aneurysmal subarachnoid hemorrhage

Peter Y M Woo  1 , Joanna W K Ho  2 , Natalie M W Ko  2 , Ronald P T Li  2 , Leo Jian  2 , Alberto C H Chu  2 , Marco C L Kwan  2 , Yung Chan  2 , Alain K S Wong  2 , Hoi-Tung Wong  2 , Kwong-Yau Chan  2 , John C K Kwok  2
Affiliations
Clinical Trial

Randomized, placebo-controlled, double-blind, pilot trial to investigate safety and efficacy of Cerebrolysin in patients with aneurysmal subarachnoid hemorrhage

Peter Y M Woo et al. BMC Neurol. .

Abstract

Asbtract: BACKGROUND: There 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.

Methods: This 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).

Results: No 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).

Conclusions: Use 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 registration: Name of Registry: ClinicalTrials.gov Trial Registration Number: NCT01787123 . Date of Registration: 8th February 2013.

Keywords: Aneurysmal subarachnoid hemorrhage; Delayed cerebral ischemia; Neuroprotection.

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Conflict of interest statement

The authors declare that they have no competing interests.

Figures

Fig. 1
Fig. 1
Trial subject profile
Fig. 2
Fig. 2
Distribution of six-month GOSE and mRS global functional outcomes for Cerebrolysin and saline group subjects
Fig. 3
Fig. 3
Forest plot. A priori subgroup analysis for favorable GOSE (5 to 8) at 6 months. n, number with favorable GOSE in each subgroup. N, total number randomized in each subgroup. TE, treatment effect. WFNS, World Federation of Neurosurgical Societies
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