Cerebrolysin after moderate to severe traumatic brain injury: prospective meta-analysis of the CAPTAIN trial series.


Journal

Neurological sciences : official journal of the Italian Neurological Society and of the Italian Society of Clinical Neurophysiology
ISSN: 1590-3478
Titre abrégé: Neurol Sci
Pays: Italy
ID NLM: 100959175

Informations de publication

Date de publication:
Nov 2021
Historique:
received: 15 10 2020
accepted: 07 12 2020
pubmed: 24 2 2021
medline: 21 10 2021
entrez: 23 2 2021
Statut: ppublish

Résumé

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. 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. 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: MW 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.

Identifiants

pubmed: 33620612
doi: 10.1007/s10072-020-04974-6
pii: 10.1007/s10072-020-04974-6
doi:

Substances chimiques

Amino Acids 0
Neuroprotective Agents 0
cerebrolysin 37KZM6S21G

Types de publication

Journal Article Meta-Analysis

Langues

eng

Sous-ensembles de citation

IM

Pagination

4531-4541

Informations de copyright

© 2021. Fondazione Società Italiana di Neurologia.

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Auteurs

Johannes C Vester (JC)

Department of Biometry and Clinical Research, idv Data Analysis and Study Planning, Gauting, Germany.

Anca D Buzoianu (AD)

Department of Pharmacology, Toxicology and Clinical Pharmacology, "Iuliu Hatieganu" University of Medicine and Pharmacy, Cluj-Napoca, Romania.

Stefan I Florian (SI)

Department of Neurosciences, "Iuliu Hatieganu" University of Medicine and Pharmacy, Cluj-Napoca, Romania.

Volker Hömberg (V)

Department of Neurology, SRH Gesundheitszentrum Bad Wimpfen GmbH, Bad Wimpfen, Germany.

Se-Hyuk Kim (SH)

Department of Neurosurgery, Ajou University School of Medicine, Suwon, South Korea.

Tatia M C Lee (TMC)

State Key Laboratory of Brain and Cognitive Sciences, the University of Hong Kong, Hong Kong, China.

Christian Matula (C)

Department of Neurosurgery, Medical University of Vienna, Vienna, Austria.

Wai Sang Poon (WS)

Division of Neurosurgery, Prince of Wales Hospital, the Chinese University of Hong Kong, Hong Kong, China.

Dorel Sandesc (D)

Department of Anesthesia and Intensive Care, "V. Babes" University of Medicine and Pharmacy, Timisoara, Romania.

Nicole von Steinbüchel (N)

Institute of Medical Psychology and Medical Sociology, University Medical Centre Göttingen, Göttingen, Germany.

Stefan Strilciuc (S)

Department of Neurosciences, "Iuliu Hatieganu" University of Medicine and Pharmacy, Cluj-Napoca, Romania.
RoNeuro Institute for Neurological Research and Diagnostic, No. 37 Mircea Eliade Street, 400487, Cluj-Napoca, Cluj, Romania.

Pieter E Vos (PE)

Department of Neurology, Slingeland Hospital, Doetinchem, The Netherlands.

Klaus von Wild (K)

Medical Faculty, Westphalia Wilhelm's University, Münster, Germany.

Dafin Muresanu (D)

Department of Neurosciences, "Iuliu Hatieganu" University of Medicine and Pharmacy, Cluj-Napoca, Romania. dafinm@ssnn.ro.
RoNeuro Institute for Neurological Research and Diagnostic, No. 37 Mircea Eliade Street, 400487, Cluj-Napoca, Cluj, Romania. dafinm@ssnn.ro.

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