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

被引:11
作者
Woo, Peter Y. M. [1 ]
Ho, Joanna W. K. [1 ]
Ko, Natalie M. W. [1 ]
Li, Ronald P. T. [1 ]
Jian, Leo [1 ]
Chu, Alberto C. H. [1 ]
Kwan, Marco C. L. [1 ]
Chan, Yung [1 ]
Wong, Alain K. S. [1 ]
Wong, Hoi-Tung [1 ]
Chan, Kwong-Yau [1 ]
Kwok, John C. K. [1 ]
机构
[1] Kwong Wah Hosp, Dept Neurosurg, Room CS11-01,11th Floor,25 Waterloo Rd, Hong Kong, Peoples R China
关键词
Aneurysmal subarachnoid hemorrhage; Neuroprotection; Delayed cerebral ischemia; PEPTIDERGIC DRUG CEREBROLYSIN; DELAYED CEREBRAL-ISCHEMIA; TRAUMATIC BRAIN-INJURY; FUNCTIONAL RECOVERY; NEUROPROTECTIVE TREATMENT; ALZHEIMERS-DISEASE; CLINICAL-TRIALS; STROKE; VASOSPASM; MULTICENTER;
D O I
10.1186/s12883-020-01908-9
中图分类号
R74 [神经病学与精神病学];
学科分类号
摘要
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.
引用
收藏
页数:14
相关论文
共 84 条
  • [1] Traumatic brain injury and intracranial hemorrhage-induced cerebral vasospasm: a systematic review
    Al-Mufti, Fawaz
    Amuluru, Krishna
    Changa, Abhinav
    Lander, Megan
    Patel, Neil
    Wajswol, Ethan
    Al-Marsoummi, Sarmad
    Alzubaidi, Basim
    Singh, I. Paul
    Nuoman, Rolla
    Gandhi, Chirag
    [J]. NEUROSURGICAL FOCUS, 2017, 43 (05)
  • [2] Efficacy and safety of Cerebrolysin in moderate to moderately severe Alzheimer's disease: results of a randomized, double-blind, controlled trial investigating three dosages of Cerebrolysin
    Alvarez, X. A.
    Cacabelos, R.
    Sampedro, C.
    Aleixandre, M.
    Linares, C.
    Granizo, E.
    Doppler, E.
    Moessler, H.
    [J]. EUROPEAN JOURNAL OF NEUROLOGY, 2011, 18 (01) : 59 - 68
  • [3] Amiri-Nikpour MR, 2014, NEUROPSYCH DIS TREAT, V10, P2299, DOI 10.2147/NDT.S75304
  • [4] A Systematic Review of Outcome Measures Employed in Aneurysmal Subarachnoid Hemorrhage (aSAH) Clinical Research
    Andersen, Christopher R.
    Fitzgerald, Emily
    Delaney, Anthony
    Finfer, Simon
    [J]. NEUROCRITICAL CARE, 2019, 30 (03) : 534 - 541
  • [5] [Anonymous], J STROKE CEREBROVASC
  • [6] Ayer R, 2010, TURK NEUROSURG, V20, P159, DOI 10.5137/1019-5149.JTN.2714-09.0
  • [7] EFFECTS OF BRAIN-TISSUE HYDROLYSATE ON SYNAPTIC TRANSMISSION IN THE HIPPOCAMPUS
    BASKYS, A
    WOJTOWICZ, JM
    [J]. PHARMACOLOGY BIOCHEMISTRY AND BEHAVIOR, 1994, 49 (04) : 1105 - 1107
  • [8] Safety and efficacy of Cerebrolysin in early post-stroke recovery: a meta-analysis of nine randomized clinical trials
    Bornstein, Natan M.
    Guekht, Alla
    Vester, Johannes
    Heiss, Wolf-Dieter
    Gusev, Eugene
    Hoemberg, Volker
    Rahlfs, Volker W.
    Bajenaru, Ovidiu
    Popescu, Bogdan O.
    Muresanu, Dafin
    [J]. NEUROLOGICAL SCIENCES, 2018, 39 (04) : 629 - 640
  • [9] The pathophysiology and treatment of delayed cerebral ischaemia following subarachnoid haemorrhage
    Budohoski, Karol P.
    Guilfoyle, Mathew
    Helmy, Adel
    Huuskonen, Terhi
    Czosnyka, Marek
    Kirollos, Ramez
    Menon, David K.
    Pickard, John D.
    Kirkpatrick, Peter J.
    [J]. JOURNAL OF NEUROLOGY NEUROSURGERY AND PSYCHIATRY, 2014, 85 (12) : 1343 - 1353
  • [10] Cerebrolysin and Aquaporin 4 Inhibition Improve Pathological and Motor Recovery after Ischemic Stroke
    Catalin, Bogdan
    Rogoveanu, Otilia-Constantina
    Pirici, Ionica
    Balseanu, Tudor Adrian
    Stan, Adina
    Tudorica, Valerica
    Balea, Maria
    Mindrila, Ion
    Albu, Carmen Valeria
    Mohamed, Guleed
    Pirici, Daniel
    Muresanu, Dafin Fior
    [J]. CNS & NEUROLOGICAL DISORDERS-DRUG TARGETS, 2018, 17 (04) : 299 - 308