Johannes C Vester1, Anca D Buzoianu2, Stefan I Florian3, Volker Hömberg4, Se-Hyuk Kim5, Tatia M C Lee6, Christian Matula7, Wai Sang Poon8, Dorel Sandesc9, Nicole von Steinbüchel10, Stefan Strilciuc3,11, Pieter E Vos12, Klaus von Wild13, Dafin Muresanu14,15. 1. Department of Biometry and Clinical Research, idv Data Analysis and Study Planning, Gauting, Germany. 2. Department of Pharmacology, Toxicology and Clinical Pharmacology, "Iuliu Hatieganu" University of Medicine and Pharmacy, Cluj-Napoca, Romania. 3. Department of Neurosciences, "Iuliu Hatieganu" University of Medicine and Pharmacy, Cluj-Napoca, Romania. 4. Department of Neurology, SRH Gesundheitszentrum Bad Wimpfen GmbH, Bad Wimpfen, Germany. 5. Department of Neurosurgery, Ajou University School of Medicine, Suwon, South Korea. 6. State Key Laboratory of Brain and Cognitive Sciences, the University of Hong Kong, Hong Kong, China. 7. Department of Neurosurgery, Medical University of Vienna, Vienna, Austria. 8. Division of Neurosurgery, Prince of Wales Hospital, the Chinese University of Hong Kong, Hong Kong, China. 9. Department of Anesthesia and Intensive Care, "V. Babes" University of Medicine and Pharmacy, Timisoara, Romania. 10. Institute of Medical Psychology and Medical Sociology, University Medical Centre Göttingen, Göttingen, Germany. 11. RoNeuro Institute for Neurological Research and Diagnostic, No. 37 Mircea Eliade Street, 400487, Cluj-Napoca, Cluj, Romania. 12. Department of Neurology, Slingeland Hospital, Doetinchem, The Netherlands. 13. Medical Faculty, Westphalia Wilhelm's University, Münster, Germany. 14. Department of Neurosciences, "Iuliu Hatieganu" University of Medicine and Pharmacy, Cluj-Napoca, Romania. dafinm@ssnn.ro. 15. RoNeuro Institute for Neurological Research and Diagnostic, No. 37 Mircea Eliade Street, 400487, Cluj-Napoca, Cluj, Romania. dafinm@ssnn.ro.
Abstract
INTRODUCTION: This prospective meta-analysis summarizes results from the CAPTAIN trial series, evaluating the effects of Cerebrolysin for moderate-severe traumatic brain injury, as an add-on to usual care. MATERIALS AND METHODS: The study included two phase IIIb/IV prospective, randomized, double-blind, placebo-controlled clinical trials. Eligible patients with a Glasgow Coma Score (GCS) between 6 and 12 received study medication (50 mL of Cerebrolysin or physiological saline solution per day for ten days, followed by two additional treatment cycles with 10 mL per day for 10 days) in addition to usual care. The meta-analysis comprises the primary ensembles of efficacy criteria for 90, 30, and 10 days after TBI with a priori ordered hypotheses based on multivariate, directional tests. RESULTS: A total 185 patients underwent meta-analysis (mean admission GCS = 10.3, mean age = 45.3, and mean Baseline Prognostic Risk Score = 2.8). The primary endpoint, a multidimensional ensemble of functional and neuropsychological outcome scales indicated a "small-to-medium" sized effect in favor of Cerebrolysin, statistically significant at Day 30 and at Day 90 (Day 30: MWcombined = 0.60, 95%CI 0.52 to 0.66, p = 0.0156; SMD = 0.31; OR = 1.69; Day 90: MWcombined = 0.60, 95%CI 0.52 to 0.68, p = 0.0146; SMD = 0.34, OR = 1.77). Treatment groups showed comparable safety and tolerability profiles. DISCUSSION: The meta-analysis of the CAPTAIN trials confirms the safety and efficacy of Cerebrolysin after moderate-severe TBI, opening a new horizon for neurorecovery in this field. Integration of Cerebrolysin into existing guidelines should be considered after careful review of internationally applicable criteria.
INTRODUCTION: This prospective meta-analysis summarizes results from the CAPTAIN trial series, evaluating the effects of Cerebrolysin for moderate-severe traumatic brain injury, as an add-on to usual care. MATERIALS AND METHODS: The study included two phase IIIb/IV prospective, randomized, double-blind, placebo-controlled clinical trials. Eligible patients with a Glasgow Coma Score (GCS) between 6 and 12 received study medication (50 mL of Cerebrolysin or physiological saline solution per day for ten days, followed by two additional treatment cycles with 10 mL per day for 10 days) in addition to usual care. The meta-analysis comprises the primary ensembles of efficacy criteria for 90, 30, and 10 days after TBI with a priori ordered hypotheses based on multivariate, directional tests. RESULTS: A total 185 patients underwent meta-analysis (mean admission GCS = 10.3, mean age = 45.3, and mean Baseline Prognostic Risk Score = 2.8). The primary endpoint, a multidimensional ensemble of functional and neuropsychological outcome scales indicated a "small-to-medium" sized effect in favor of Cerebrolysin, statistically significant at Day 30 and at Day 90 (Day 30: MWcombined = 0.60, 95%CI 0.52 to 0.66, p = 0.0156; SMD = 0.31; OR = 1.69; Day 90: MWcombined = 0.60, 95%CI 0.52 to 0.68, p = 0.0146; SMD = 0.34, OR = 1.77). Treatment groups showed comparable safety and tolerability profiles. DISCUSSION: The meta-analysis of the CAPTAIN trials confirms the safety and efficacy of Cerebrolysin after moderate-severe TBI, opening a new horizon for neurorecovery in this field. Integration of Cerebrolysin into existing guidelines should be considered after careful review of internationally applicable criteria.
Authors: Steven Laureys; Gastone G Celesia; Francois Cohadon; Jan Lavrijsen; José León-Carrión; Walter G Sannita; Leon Sazbon; Erich Schmutzhard; Klaus R von Wild; Adam Zeman; Giuliano Dolce Journal: BMC Med Date: 2010-11-01 Impact factor: 8.775
Authors: Wai Poon; Pieter Vos; Dafin Muresanu; Johannes Vester; Klaus von Wild; Volker Hömberg; Ernest Wang; Tatia M C Lee; Christian Matula Journal: J Neurotrauma Date: 2015-01-28 Impact factor: 5.269