Home › Research › Clinical trials
Cerebrolysin Asian Pacific Trial in Acute Brain Injury and Neurorecovery: Design and Methods
Wai Poon, Pieter Vos, Dafin Muresanu, Johannes Vester, Klaus von Wild, Volker Hömberg, Ernest Wang, Tatia M.C. Lee et al.. Journal of Neurotrauma, 2015-04
Topic: Drug trials: efficacy and safety
Traumatic brain injury (TBI) is one of the leading causes of injury-related death. In the United States alone, an estimated 1.7 million people sustain a TBI each year, and approximately 5.3 million people live with a TBI-related disability. The direct medical costs and indirect costs such as lost productivity of TBIs totaled an estimated $76.5 billion in the U.S. in the year 2000. Improving the limited treatment options for this condition remains challenging. However, recent reports from interdisciplinary working groups (consisting primarily of neurologists, neurosurgeons, neuropsychologists, and biostatisticians) have stated that to improve TBI treatment, important methodological lessons from the past must be taken into account in future clinical research. An evaluation of the neuroprotection intervention studies conducted over the last 30 years has indicated that a limited understanding of the underlying biological concepts and methodological design flaws are the major reasons for the failure of pharmacological agents to demonstrate efficacy. Cerebrolysin is a parenterally-administered neuro-peptide preparation that acts in a manner similar to endogenous neurotrophic factors. Cerebrolysin has a favorable adverse effect profile, and several meta-analyses have suggested that Cerebrolysin is beneficial as a dementia treatment. CAPTAIN is a randomized, double-blind, placebo-controlled, multi-center, multinational trial of the effects of Cerebrolysin on neuroprotection and neurorecovery after TBI using a multidimensional ensemble of outcome scales. The CAPTAIN trial will be the first TBI trial with a ‘true’ multidimensional approach based on full outcome scales, while avoiding prior weaknesses, such as loss of information through “dichotomization,” or unrealistic assumptions such as “normal distribution.”
Key findings
- An evaluation of the neuroprotection intervention studies conducted over the last 30 years has indicated that a limited understanding of the underlying biological concepts and methodological design flaws are the major reasons for the failure of pharmacological agents to demonstrate efficacy.
- Cerebrolysin has a favorable adverse effect profile, and several meta-analyses have suggested that Cerebrolysin is beneficial as a dementia treatment.
New to this subject? Start with our plain-English guide: Registered clinical trials →
Study details
- Study designmeta-analysis
- Evidence strengthHigh
How this study scored 64/100
Published in a peer-reviewed journal, and it is a meta-analysis pooling many studies. Scored zero for sample size, effect reported and studied in people because the record does not state it. We have no data on journal's citation record, times cited, citations per year, impact for its field and year, cited by studies here, still being cited, senior author's track record, institution's track record, multi-centre collaboration and free to read, so those were left out: it earned 36 of the 56 points we could judge it on, which is 64 out of 100.
| Component | Points | Why |
|---|---|---|
| Journal tier | 7 / 10 | Tier 3 — peer-reviewed journal (Journal of Neurotrauma) |
| Journal's citation record | — / 4 | No journal record from OpenAlex — left out of this score |
| Study design | 12 / 12 | A meta-analysis pooling many studies |
| Strength of evidence | 5 / 5 | Rated “high” in our summary |
| Peer-review validation | 10 / 10 | Peer-reviewed. Published as an article in a named peer-reviewed journal. |
| How recent | 1 / 5 | 2015 — within 20 year(s) of the newest study here |
| Sample size | 0 / 4 | Participant count not stated — scores zero (not stated in the record — scored 0) |
| Effect reported | 0 / 3 | No effect size reported — scores zero (not stated in the record — scored 0) |
| Studied in people | 0 / 3 | Not stated whether this was studied in people — scores zero (not stated in the record — scored 0) |
| Randomised / blinded | 0 / 2 | A review of other studies — randomisation is not credited here |
| Times cited | — / 7 | No citation count (not found in OpenAlex) — left out of this score |
| Citations per year | — / 5 | No citation count or no year — left out of this score |
| Impact for its field and year | — / 6 | No field-weighted citation impact (OpenAlex has none yet) — left out of this score |
| Cited by studies here | — / 6 | Not yet checked against this library's citation graph — left out of this score |
| Still being cited | — / 4 | No yearly citation counts — left out of this score |
| Senior author's track record | — / 4 | Senior author's record not available — left out of this score |
| Institution's track record | — / 3 | No institution listed in OpenAlex — left out of this score |
| Multi-centre collaboration | — / 3 | Institutions not listed — left out of this score |
| Indexed in PubMed | 1 / 2 | Not in PubMed, but has a DOI |
| Free to read | — / 2 | Access not recorded — left out of this score |
| Points | 36 / 56 | Scored on 10 of 20 parts. We have no data for the rest, so they are left out: 36 of the 56 points we could judge it on is 64 out of 100. |
| Total | 64 / 100 | — |
What each of these 20 components measures, and what this score is not →
Read the original
Free copy unknown: no free-copy check has an answer for this record yet. That does not mean it is paywalled.
Cite this study APA, Vancouver, BibTeX · download .bib or .ris
Built from the record alzhub holds for this paper, not looked up. Volume, issue and page numbers are not held in the record. The record's author list ends in “et al.”, so not every author is named. Check the citation against the original before you use it.
APA 7th
Poon, W., Vos, P., Muresanu, D., Vester, J., von Wild, K., Hömberg, V., et al. (2015). Cerebrolysin Asian Pacific Trial in Acute Brain Injury and Neurorecovery: Design and Methods. Journal of Neurotrauma. https://doi.org/10.1089/neu.2014.3558
Vancouver
Poon W, Vos P, Muresanu D, Vester J, von Wild K, Hömberg V, et al. Cerebrolysin Asian Pacific Trial in Acute Brain Injury and Neurorecovery: Design and Methods. Journal of Neurotrauma. 2015. doi:10.1089/neu.2014.3558.
BibTeX
@article{poon2015-a031a0f8,
author = {Poon, Wai and Vos, Pieter and Muresanu, Dafin and Vester, Johannes and von Wild, Klaus and Hömberg, Volker and Wang, Ernest and Lee, Tatia M.C. and others},
title = {{Cerebrolysin Asian Pacific Trial in Acute Brain Injury and Neurorecovery: Design and Methods}},
journal = {Journal of Neurotrauma},
year = {2015},
doi = {10.1089/neu.2014.3558},
url = {https://doi.org/10.1089/neu.2014.3558}
}
Related studies in Clinical trials
Also tagged “hydrocephalus”
73 studies in the library carry the topic tag “hydrocephalus”; these are this study's neighbours in a fixed, alphabetical-by-hash tour of them, not the closest in content. All 73 tagged studies.