Randomized, placebo-controlled, double-blind, pilot trial to investigate safety and efficacy of Cerebrolysin in patients with aneurysmal subarachnoid hemorrhage
| العنوان: | Randomized, placebo-controlled, double-blind, pilot trial to investigate safety and efficacy of Cerebrolysin in patients with aneurysmal subarachnoid hemorrhage |
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| المؤلفون: | Alberto Chi Ho Chu, Alain K.S. Wong, John C. K. Kwok, Peter Y.M. Woo, Yung Chan, Natalie M.W. Ko, Marco Cheuk-Lun Kwan, Ronald P. T. Li, Hoi-Tung Wong, Leo Jian, Joanna W. K. Ho, Kwong-Yau Chan |
| المصدر: | BMC Neurology, Vol 20, Iss 1, Pp 1-14 (2020) BMC Neurology |
| بيانات النشر: | Springer Science and Business Media LLC, 2020. |
| سنة النشر: | 2020 |
| مصطلحات موضوعية: | Adult, Male, Subarachnoid hemorrhage, Aneurysmal subarachnoid hemorrhage, Glasgow Outcome Scale, Pilot Projects, Placebo, lcsh:RC346-429, Brain Ischemia, chemistry.chemical_compound, Double-Blind Method, medicine, Clinical endpoint, Humans, Prospective Studies, Amino Acids, Adverse effect, Delayed cerebral ischemia, lcsh:Neurology. Diseases of the nervous system, Aged, business.industry, Montreal Cognitive Assessment, General Medicine, Odds ratio, Middle Aged, Subarachnoid Hemorrhage, medicine.disease, Neuroprotection, Neuroprotective Agents, Treatment Outcome, chemistry, Cerebrolysin, Anesthesia, Female, Neurology (clinical), business, Research Article |
| الوصف: | 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. |
| تدمد: | 1471-2377 |
| URL الوصول: | https://explore.openaire.eu/search/publication?articleId=doi_dedup___::3e42bae4096ac96c8a8410638be774aa https://doi.org/10.1186/s12883-020-01908-9 |
| حقوق: | OPEN |
| رقم الأكسشن: | edsair.doi.dedup.....3e42bae4096ac96c8a8410638be774aa |
| قاعدة البيانات: | OpenAIRE |
Find this article in full text from Springer Verlag. | تدمد: | 14712377 |
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