In patients with moderate-severe traumatic brain injury, Cerebrolysin improved the multidimensional primary endpoint versus placebo at day 90.
In plain wordsIn patients with moderate-severe brain injury, Cerebrolysin improved the combined primary outcome more than placebo at day 90.
- Peptide
- Cerebrolysin
- Outcome
- IncreaseMultidimensional ensemble of outcome scales at day 90
- Study
n = 139
- Comparator
- Physiological saline placebo plus standard care
- Analysis
- Primary
- Outcome group
- Neuroprotection · Nervous system and cognition
- Studied dose
- 50 ml/day for 10 days, then two cycles of 10 ml/day for 10 daysAs given in this study (human).
Measurements
- MW combined
- 0.59
- day 90
- P
- 0.0119
- primary endpoint
- 95% confidence interval for MW combined
- 0.52 to 0.66
- Cerebrolysin versus placebo, primary endpoint at day 90
Source sentences
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 (MWcombined = 0.59, 95% CI 0.52 to 0.66, P = 0.0119).
4 context sentences(design, population, supporting numbers)
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 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.
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).