Evidence map›Paper›PMID 31897941›Full record

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

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

Dafin F Muresanu, Stefan Florian, Volker Hömberg, Christian Matula, Nicole von Steinbüchel, Pieter E Vos, Klaus von Wild, Codruta Birle, Ioana Muresanu, Dana Slavoaca and 3 more

Registry-linked trialAbstract readRandomized Controlled Trial
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. It is linked to trial NCT06052787 (The Impact and Outcomes of Combined Cerebrolysin and Amantadine Sulfate Administration on Management of Patients With Traumatic Brain Injury in the ICU), which is not on this map. Cited by 36 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
36citing papers in PubMed, 3 pooled it
–field-weighted citation impact
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.

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

36 citing papers in PubMed, 3 syntheses or guidelines pooled it.

  1. Pooled it
  2. 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
    Pooled it
  3. Sensory stimulation to improve arousal in comatose patients after traumatic brain injury: a systematic review of the literature.Neurological sciences : official journal of the Italian Neurological Society and of the Italian Society of Clinical Neurophysiology · 2020
    Pooled it
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

13 authors.

Dafin F MuresanuDepartment of Neurosciences, "Iuliu Hatieganu", University of Medicine and Pharmacy, No. 43 Victor Babes Street, 400012, Cluj-Napoca, Romania. dafinm@ssnn.ro.ORCID http://orcid.org/0000-0002-9536-1153
Stefan FlorianDepartment of Neurosciences, "Iuliu Hatieganu", University of Medicine and Pharmacy, No. 43 Victor Babes Street, 400012, Cluj-Napoca, Romania.
Volker HömbergDepartment of Neurology, SRH Gesundheitszentrum Bad Wimpfen GmbH, Bei der alten Saline 2, 74206, Bad Wimpfen, Germany.
Christian MatulaDepartment of Neurosurgery, Medical University of Vienna, Vienna, Austria.
Nicole von SteinbüchelInstitute of Medical Psychology and Medical Sociology, University Medical Centre Göttingen, Göttingen, Germany.
Pieter E VosDepartment of Neurology, Slingeland Hospital, Kruisbergseweg 25, 7009 BL, Doetinchem, Netherlands.
Klaus von WildMedical Faculty, Westphalia Wilhelm's University, Münster, Germany.
Codruta BirleDepartment of Neurosciences, "Iuliu Hatieganu", University of Medicine and Pharmacy, No. 43 Victor Babes Street, 400012, Cluj-Napoca, Romania.
Ioana MuresanuDepartment of Neurosciences, "Iuliu Hatieganu", University of Medicine and Pharmacy, No. 43 Victor Babes Street, 400012, Cluj-Napoca, Romania.
Dana SlavoacaDepartment of Neurosciences, "Iuliu Hatieganu", University of Medicine and Pharmacy, No. 43 Victor Babes Street, 400012, Cluj-Napoca, Romania.
Olivia Verisezan RosuDepartment of Neurosciences, "Iuliu Hatieganu", University of Medicine and Pharmacy, No. 43 Victor Babes Street, 400012, Cluj-Napoca, Romania.
Stefan StrilciucDepartment of Neurosciences, "Iuliu Hatieganu", University of Medicine and Pharmacy, No. 43 Victor Babes Street, 400012, Cluj-Napoca, Romania.
Johannes VesterDepartment of Biometry and Clinical Research, idv Data Analysis and Study Planning, Gauting, Germany.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionThe 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

methodsThe 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.

resultsThe 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

conclusionOur 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.

Indexed as

AdultAmino AcidsBrain Injuries, TraumaticDouble-Blind MethodFemaleGlasgow Coma ScaleHumansMaleMiddle AgedNeuroprotective AgentsNeuropsychological TestsProspective StudiesSeverity of Illness IndexTreatment OutcomeAmino AcidscerebrolysinNeuroprotective AgentsCerebrolysinMultidimensional approachTraumatic brain injuryWei-Lachin pooling

Identifiers

PMID31897941

What OpenQuestion holds

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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.