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- Publisher Website: 10.1007/s10072-019-04053-5
- Scopus: eid_2-s2.0-85073945466
- PMID: 31494820
- WOS: WOS:000499860400001
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Article: Safety and efficacy of Cerebrolysin in acute brain injury and neurorecovery: CAPTAIN I—a randomized, placebo-controlled, double-blind, Asian-Pacific trial
Title | Safety and efficacy of Cerebrolysin in acute brain injury and neurorecovery: CAPTAIN I—a randomized, placebo-controlled, double-blind, Asian-Pacific trial |
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Authors | |
Keywords | Cerebrolysin Multidimensional approach Traumatic brain injury Wei-Lachin pooling |
Issue Date | 2020 |
Citation | Neurological Sciences, 2020, v. 41, n. 2, p. 281-293 How to Cite? |
Abstract | Objective: To evaluate the safety and efficacy of Cerebrolysin as an add-on therapy to local standard treatment protocol in patients after moderate-to-severe traumatic brain injury. Methods: The patients received the study medication in addition to standard care (50 mL of Cerebrolysin or physiological saline solution daily for 10 days, followed by two additional treatment cycles with 10 mL daily for 10 days) in a prospective, randomized, double-blind, placebo-controlled, parallel-group, multi-centre phase IIIb/IV trial. The primary endpoint was a multidimensional ensemble of 14 outcome scales pooled to be analyzed by means of the multivariate, correlation-sensitive Wei-Lachin procedure. Results: In 46 enrolled TBI patients (Cerebrolysin 22, placebo 24), three single outcomes showed stand-alone statistically significant superiority of Cerebrolysin [Stroop Word/Dots Interference (p = 0.0415, Mann–Whitney(MW) = 0.6816, 95% CI 0.51–0.86); Color Trails Tests 1 and 2 (p = 0.0223/0.0170, MW = 0.72/0.73, 95% CI 0.53–0.90/0.54–0.91), both effect sizes lying above the benchmark for “large” superiority (MW > 0.71)]. While for the primary multivariate ensemble, statistical significance was just missed in the intention-to-treat population (pWei-Lachin < 0.1, MWcombined = 0.63, 95% CI 0.48–0.77, derived standardized mean difference (SMD) 0.45, 95% CI −0.07 to 1.04, derived OR 2.1, 95% CI 0.89–5.95), the per-protocol analysis showed a statistical significant superiority of Cerebrolysin (pWei-Lachin = 0.0240, MWcombined = 0.69, 95% CI 0.53 to 0.85, derived SMD 0.69, 95% CI 0.09 to 1.47, derived OR 3.2, 95% CI 1.16 to 12.8), with effect sizes of six single outcomes lying above the benchmark for “large” superiority. Safety aspects were comparable to placebo. Conclusion: Our trial suggests beneficial effects of Cerebrolysin on outcome after TBI. Results should be confirmed by a larger RCT with a comparable multidimensional approach. |
Persistent Identifier | http://hdl.handle.net/10722/325448 |
ISSN | 2023 Impact Factor: 2.7 2023 SCImago Journal Rankings: 0.738 |
ISI Accession Number ID | |
Errata |
DC Field | Value | Language |
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dc.contributor.author | Poon, W. | - |
dc.contributor.author | Matula, C. | - |
dc.contributor.author | Vos, P. E. | - |
dc.contributor.author | Muresanu, D. F. | - |
dc.contributor.author | von Steinbüchel, N. | - |
dc.contributor.author | von Wild, K. | - |
dc.contributor.author | Hömberg, V. | - |
dc.contributor.author | Wang, E. | - |
dc.contributor.author | Lee, T. M.C. | - |
dc.contributor.author | Strilciuc, S. | - |
dc.contributor.author | Vester, J. C. | - |
dc.date.accessioned | 2023-02-27T07:33:24Z | - |
dc.date.available | 2023-02-27T07:33:24Z | - |
dc.date.issued | 2020 | - |
dc.identifier.citation | Neurological Sciences, 2020, v. 41, n. 2, p. 281-293 | - |
dc.identifier.issn | 1590-1874 | - |
dc.identifier.uri | http://hdl.handle.net/10722/325448 | - |
dc.description.abstract | Objective: To evaluate the safety and efficacy of Cerebrolysin as an add-on therapy to local standard treatment protocol in patients after moderate-to-severe traumatic brain injury. Methods: The patients received the study medication in addition to standard care (50 mL of Cerebrolysin or physiological saline solution daily for 10 days, followed by two additional treatment cycles with 10 mL daily for 10 days) in a prospective, randomized, double-blind, placebo-controlled, parallel-group, multi-centre phase IIIb/IV trial. The primary endpoint was a multidimensional ensemble of 14 outcome scales pooled to be analyzed by means of the multivariate, correlation-sensitive Wei-Lachin procedure. Results: In 46 enrolled TBI patients (Cerebrolysin 22, placebo 24), three single outcomes showed stand-alone statistically significant superiority of Cerebrolysin [Stroop Word/Dots Interference (p = 0.0415, Mann–Whitney(MW) = 0.6816, 95% CI 0.51–0.86); Color Trails Tests 1 and 2 (p = 0.0223/0.0170, MW = 0.72/0.73, 95% CI 0.53–0.90/0.54–0.91), both effect sizes lying above the benchmark for “large” superiority (MW > 0.71)]. While for the primary multivariate ensemble, statistical significance was just missed in the intention-to-treat population (pWei-Lachin < 0.1, MWcombined = 0.63, 95% CI 0.48–0.77, derived standardized mean difference (SMD) 0.45, 95% CI −0.07 to 1.04, derived OR 2.1, 95% CI 0.89–5.95), the per-protocol analysis showed a statistical significant superiority of Cerebrolysin (pWei-Lachin = 0.0240, MWcombined = 0.69, 95% CI 0.53 to 0.85, derived SMD 0.69, 95% CI 0.09 to 1.47, derived OR 3.2, 95% CI 1.16 to 12.8), with effect sizes of six single outcomes lying above the benchmark for “large” superiority. Safety aspects were comparable to placebo. Conclusion: Our trial suggests beneficial effects of Cerebrolysin on outcome after TBI. Results should be confirmed by a larger RCT with a comparable multidimensional approach. | - |
dc.language | eng | - |
dc.relation.ispartof | Neurological Sciences | - |
dc.subject | Cerebrolysin | - |
dc.subject | Multidimensional approach | - |
dc.subject | Traumatic brain injury | - |
dc.subject | Wei-Lachin pooling | - |
dc.title | Safety and efficacy of Cerebrolysin in acute brain injury and neurorecovery: CAPTAIN I—a randomized, placebo-controlled, double-blind, Asian-Pacific trial | - |
dc.type | Article | - |
dc.description.nature | link_to_subscribed_fulltext | - |
dc.identifier.doi | 10.1007/s10072-019-04053-5 | - |
dc.identifier.pmid | 31494820 | - |
dc.identifier.scopus | eid_2-s2.0-85073945466 | - |
dc.identifier.volume | 41 | - |
dc.identifier.issue | 2 | - |
dc.identifier.spage | 281 | - |
dc.identifier.epage | 293 | - |
dc.identifier.eissn | 1590-3478 | - |
dc.identifier.isi | WOS:000499860400001 | - |
dc.relation.erratum | doi:10.1007/s10072-019-04149-y | - |
dc.relation.erratum | eid:eid_2-s2.0-85077604762 | - |