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01-05-2020 | Central Nervous System Trauma | Original Article

Efficacy and safety of cerebrolysin in neurorecovery after moderate-severe traumatic brain injury: results from the CAPTAIN II trial

Authors: Dafin F Muresanu, Stefan Florian, Volker Hömberg, Christian Matula, Nicole von Steinbüchel, Pieter E Vos, Klaus von Wild, Codruta Birle, Ioana Muresanu, Dana Slavoaca, Olivia Verisezan Rosu, Stefan Strilciuc, Johannes Vester

Published in: Neurological Sciences | Issue 5/2020

Abstract

Introduction

The objective of this trial was to evaluate the efficacy and safety of Cerebrolysin in treating patients after moderate to severe traumatic brain injury (TBI) as an adjunct to standard care protocols. The trial was designed to investigate the clinical effects of Cerebrolysin in the acute (neuroprotective) stage and during early and long-term recovery as part of a neurorestorative strategy.

Materials and methods

The study was a phase IIIb/IV single-center, prospective, randomized, double-blind, placebo-controlled clinical trial. Eligible patients with a Glasgow Coma Score (GCS) between 7 and 12 received study medication (50 ml of Cerebrolysin or physiological saline solution per day for 10 days, followed by two additional treatment cycles with 10 ml per day for 10 days) in addition to standard care. We tested ensembles of efficacy criteria for 90, 30, and 10 days after TBI with a priori ordered hypotheses using a multivariate, directional test, to reflect the global status of patients after TBI.

Results

The study enrolled 142 patients, of which 139 underwent formal analysis (mean age = 47.4, mean admission GCS = 10.4, and mean Baseline Prognostic Risk Score = 2.6). The primary endpoint, a multidimensional ensemble of 13 outcome scales, indicated a “small-to-medium”–sized effect in favor of Cerebrolysin, statistically significant at day 90 (MW_combined = 0.59, 95% CI 0.52 to 0.66, P = 0.0119). Safety and tolerability observations were comparable between treatment groups.

Conclusion

Our trial confirms previous beneficial effects of the multimodal, biological agent Cerebrolysin for overall outcome after moderate to severe TBI, as measured by a multidimensional approach. Study findings must be appraised and aggregated in conjunction with existing literature, as to improve the overall level of insight regarding therapeutic options for TBI patients. The widely used pharmacologic intervention may benefit from a large-scale observational study to map its use and to establish comparative effectiveness in real-world clinical settings.

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Title: Efficacy and safety of cerebrolysin in neurorecovery after moderate-severe traumatic brain injury: results from the CAPTAIN II trial
Authors: Dafin F Muresanu
Stefan Florian
Volker Hömberg
Christian Matula
Nicole von Steinbüchel
Pieter E Vos
Klaus von Wild
Codruta Birle
Ioana Muresanu
Dana Slavoaca
Olivia Verisezan Rosu
Stefan Strilciuc
Johannes Vester
Publication date: 01-05-2020
Publisher: Springer International Publishing
Keyword: Central Nervous System Trauma
Published in: Neurological Sciences / Issue 5/2020
Print ISSN: 1590-1874
Electronic ISSN: 1590-3478
DOI: https://doi.org/10.1007/s10072-019-04181-y

At a glance: The STEP trials

Springer Medicine

Efficacy and safety of cerebrolysin in neurorecovery after moderate-severe traumatic brain injury: results from the CAPTAIN II trial

Abstract

Introduction

Materials and methods

Results

Conclusion

At a glance: The STEP trials

Springer Medicine

Abstract

Introduction

Materials and methods

Results

Conclusion

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