Evidence map›Paper›PMID 31494820›Full record

Trial reportNeurological sciences : official journal of the Italian Neurological Society and of the Italian Society of Clinical Neurophysiology2020

Safety and efficacy of Cerebrolysin in acute brain injury and neurorecovery: CAPTAIN I-a randomized, placebo-controlled, double-blind, Asian-Pacific trial.

W Poon, C Matula, P E Vos, D F Muresanu, N von Steinbüchel, K von Wild, V Hömberg, E Wang, T M C Lee, S Strilciuc and 1 more

Erratum issued 2 registry-linked trialsOpen access · greenAbstract readClinical Trial, Phase IIIClinical Trial, Phase IVMulticenter Study
PubMed Publisher
In one paragraph

Trial report in Neurological sciences : official journal of the Italian Neurological Society and of the Italian Society of Clinical Neurophysiology, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to 2 registered trials, which are not on this map. Cited by 28 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
28citing papers in PubMed, 1 pooled it
2.0field-weighted citation impact, top 13% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT01606111 phase4terminatednot on this map

A Randomized, Double-blind, Placebo-controlled Trial to Investigate Safety and Efficacy of Cerebrolysin in Patients With Traumatic Brain Injury

TypeinterventionalSponsorEver Neuro Pharma GmbHRan2013 to 2015Enrolled46ConditionsTraumatic Brain InjuryArmsCerebrolysin, 0.9% NaCl, saline
NCT06052787 phase3completednot on this mapstarted 2023, after this paper: background citation

The Impact and Outcomes of Combined Cerebrolysin and Amantadine Sulfate Administration on Management of Patients With Traumatic Brain Injury in the ICU

TypeinterventionalSponsorAin Shams UniversityRan2023 to 2025Enrolled150ConditionsTraumatic Brain InjuryArmsCerebrolysin, amantadine sulfate
3 · Its place in the literature

Who cites it

28 citing papers in PubMed, 1 synthesis or guideline pooled it, 40 citations in OpenAlex.

  1. Cerebrolysin after moderate to severe traumatic brain injury: prospective meta-analysis of the CAPTAIN trial series.Neurological sciences : official journal of the Italian Neurological Society and of the Italian Society of Clinical Neurophysiology · 2021
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  3. Efficacy and safety of cerebrolysin in neurorecovery after moderate-severe traumatic brain injury: results from the CAPTAIN II trial.Neurological sciences : official journal of the Italian Neurological Society and of the Italian Society of Clinical Neurophysiology · 2020
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

11 authors at 9 institutions in 7 countries.

W PoonDivision of Neurosurgery, Prince of Wales Hospital, The Chinese University of Hong Kong, Shatin, Hong Kong, China.
C MatulaDepartment of Neurosurgery, Medical University of Vienna, Vienna, Austria.
P E VosDepartment of Neurology, Slingeland Hospital, Doetinchem, The Netherlands.
D F MuresanuDepartment of Clinical Neurosciences, "Iuliu Hatieganu" University of Medicine and Pharmacy, Cluj-Napoca, Romania. dafinm@ssnn.ro.ORCID http://orcid.org/0000-0002-9536-1153
N von SteinbüchelInstitute of Medical Psychology and Medical Sociology, University Medical Centre Göttingen, Göttingen, Germany.
K von WildMedical Faculty, Westphalia Wilhelm's University, Münster, Germany.
V HömbergDepartment of Neurology, SRH Gesundheitszentrum Bad Wimpfen GmbH, Bad Wimpfen, Germany.
E WangDepartment of Neurosurgery, National Neuroscience Institute, Singapore, Singapore.
T M C LeeState Key Laboratory of Brain and Cognitive Sciences and Laboratory of Neuropsychology, The University of Hong Kong, Pokfulam, Hong Kong, China.
S StrilciucDepartment of Clinical Neurosciences, "Iuliu Hatieganu" University of Medicine and Pharmacy, Cluj-Napoca, Romania.
J C VesterDepartment of Biometry and Clinical Research, idv Data Analysis and Study Planning, Krailling, Germany.
Iuliu Hațieganu University of Medicine and Pharmacy · ROChinese University of Hong Kong · HKMedical University of Vienna · ATNational Neuroscience Institute · SGPHV Dialysezentrum · DESlingeland Ziekenhuis · NLUniversity of Hong Kong · HKUniversity of Münster · DEZimmer Biomet (Germany) · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveTo 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.

methodsThe 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.

resultsIn 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 (p

conclusionOur trial suggests beneficial effects of Cerebrolysin on outcome after TBI. Results should be confirmed by a larger RCT with a comparable multidimensional approach.

Indexed as

Outcome Assessment, Health CareAcute DiseaseAdultAmino AcidsAsia, EasternAsia, SoutheasternBrain Injuries, TraumaticCognitive DysfunctionDouble-Blind MethodFemaleHumansMaleMiddle AgedNeuroprotective AgentsSeverity of Illness IndexYoung AdultAmino AcidscerebrolysinNeuroprotective AgentsCerebrolysinMultidimensional approachTraumatic brain injuryWei-Lachin pooling

Identifiers

PMID31494820
OpenAlexW2971798314

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.