Cerebrolysin in traumatic brain injury: recovery outcomes in CAPTAIN II

Level of evidence: Human randomized study; clinical formulation

Research question

How was neurological recovery after moderate to severe traumatic brain injury studied using a clinical Cerebrolysin formulation?

Study design

CAPTAIN II was a prospective, randomized, double-blind, placebo-controlled single-center study. The clinical study intervention was added to standard care.

What was found?

Of 142 participants, 139 were formally analyzed. The primary composite endpoint of 13 outcome scales showed a small to moderate effect in favor of Cerebrolysin on day 90. The difference was statistically significant. Safety and tolerability findings were comparable between the groups.

Limitations and interpretation

The composite endpoint is not equivalent to complete neurological recovery. The study was conducted at a single center; confirmation and assessment alongside other studies remain necessary. The clinical formulation and intensive medical care are not equivalent to a standalone research product.

Original publication

Efficacy and safety of cerebrolysin in neurorecovery after moderate-severe traumatic brain injury: results from the CAPTAIN II trial. PMID: 31897941. View the original publication on PubMed.

This summary is based on the available source description and abstract; it is not a complete systematic review.

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