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

TitleCerebrolysin after moderate to severe traumatic brain injury: prospective meta-analysis of the CAPTAIN trial series
Authors
KeywordsModerate-severe traumatic brain injury
Cerebrolysin
Issue Date2021
PublisherSpringer-Verlag Italia Srl. The Journal's web site is located at http://www.springer.it/libri_libro.asp?id=249
Citation
Neurological Sciences, 2021, v. 42 n. 11, p. 4531-4541 How to Cite?
AbstractIntroduction: 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.
Persistent Identifierhttp://hdl.handle.net/10722/306124
ISSN
2023 Impact Factor: 2.7
2023 SCImago Journal Rankings: 0.738
ISI Accession Number ID

 

DC FieldValueLanguage
dc.contributor.authorVester, JC-
dc.contributor.authorBuzoianu, AD-
dc.contributor.authorFlorian, SI-
dc.contributor.authorHömberg, V-
dc.contributor.authorKim, S-
dc.contributor.authorLee, TMC-
dc.contributor.authorMatula, C-
dc.contributor.authorPoon, WS-
dc.contributor.authorSandesc, D-
dc.contributor.authorvon Steinbüchel, N-
dc.contributor.authorStrilciuc, S-
dc.contributor.authorVos, PE-
dc.contributor.authorvon Wild, K-
dc.contributor.authorMuresanu, D-
dc.date.accessioned2021-10-20T10:19:08Z-
dc.date.available2021-10-20T10:19:08Z-
dc.date.issued2021-
dc.identifier.citationNeurological Sciences, 2021, v. 42 n. 11, p. 4531-4541-
dc.identifier.issn1590-1874-
dc.identifier.urihttp://hdl.handle.net/10722/306124-
dc.description.abstractIntroduction: 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.-
dc.languageeng-
dc.publisherSpringer-Verlag Italia Srl. The Journal's web site is located at http://www.springer.it/libri_libro.asp?id=249-
dc.relation.ispartofNeurological Sciences-
dc.subjectModerate-severe traumatic brain injury-
dc.subjectCerebrolysin-
dc.titleCerebrolysin after moderate to severe traumatic brain injury: prospective meta-analysis of the CAPTAIN trial series-
dc.typeArticle-
dc.identifier.emailLee, TMC: tmclee@hku.hk-
dc.identifier.authorityLee, TMC=rp00564-
dc.description.naturelink_to_subscribed_fulltext-
dc.identifier.doi10.1007/s10072-020-04974-6-
dc.identifier.pmid33620612-
dc.identifier.scopuseid_2-s2.0-85101401237-
dc.identifier.hkuros328009-
dc.identifier.volume42-
dc.identifier.issue11-
dc.identifier.spage4531-
dc.identifier.epage4541-
dc.identifier.isiWOS:000620911100003-
dc.publisher.placeItaly-

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