Efficacy and safety of compound porcine cerebroside and ganglioside injection (CPCGI) versus piracetam on cognition and functional outcomes for adults with traumatic brain injury: A study protocol for randomized controlled trial – PubMed Black Hawk Supplements

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BACKGROUND: Traumatic brain injury (TBI) is a common neurosurgical disease in emergency rooms with poor prognosis, imposing severe burdens on patients and their families. Evidence indicates that piracetam and compound porcine cerebroside and ganglioside injection (CPCGI) can improve cognitive levels in TBI patients to enhance functional prognosis, but there is still a research gap regarding the efficacy of CPCGI. This study aims to determine the effectiveness and safety of CPCGI in improving…
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Efficacy and safety of compound porcine cerebroside and ganglioside injection (CPCGI) versus piracetam on cognition and functional outcomes for adults with traumatic brain injury: A study protocol for randomized controlled trial - PubMed

. 2024 Aug 31;10(17):e37296.

doi: 10.1016/j.heliyon.2024.e37296. eCollection 2024 Sep 15.

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Efficacy and safety of compound porcine cerebroside and ganglioside injection (CPCGI) versus piracetam on cognition and functional outcomes for adults with traumatic brain injury: A study protocol for randomized controlled trial

Tao Liu et al. Heliyon. .

Abstract

Background: Traumatic brain injury (TBI) is a common neurosurgical disease in emergency rooms with poor prognosis, imposing severe burdens on patients and their families. Evidence indicates that piracetam and compound porcine cerebroside and ganglioside injection (CPCGI) can improve cognitive levels in TBI patients to enhance functional prognosis, but there is still a research gap regarding the efficacy of CPCGI. This study aims to determine the effectiveness and safety of CPCGI in improving cognitive and functional outcomes in TBI patients.

Methods: This study is a multicenter, randomized, parallel-group, double-blind trial aiming to recruit 900 adult patients with mild to moderate TBI. After providing informed consent, 600 patients will be randomly assigned to the CPCGI group (20 ml/d, for 14 days), and 300 patients will be randomized to the piracetam group as a control (20 ml/d, for 14 days), followed up for 3 months after treatment. The primary outcome is the change in the Montreal Cognitive Assessment (MoCA) score from baseline after 3 months. The main secondary outcome measures include Mini-Mental State Examination (MMSE) scores, Glasgow Outcome Scale-Extended (GOS-E), and the Barthel Index at 1 and 3 months.

Discussion: This multi-center clinical trial aims to provide high-quality evidence on the efficacy and safety of CPCGI in improving cognitive and functional outcomes in mild to moderate TBI patients.

Trial registration: ChiCTR2000040466, date of registration: November 28, 2020.

Keywords: Cognitive; Compound porcine cerebroside and ganglioside injection; Outcome; Piracetam; Randomized controlled trial; Traumatic brain injury.

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Conflict of interest statement

The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.

Figures

Fig. 1
Fig. 1

Flow chart to illustrate the design of the trial. TBI traumatic brain injury, CPCGI compound porcine cerebroside and ganglioside injection, MoCA Montreal Cognitive Assessment, MMSE Mini-Mental State Examination, GCS Glasgow Coma Scale, NIHSS National Institutes of Health Stroke Scale, GOS-E Glasgow Outcome Scale-Extended, AEs adverse events, ECG electrocardiogram.

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Efficacy and safety of compound porcine cerebroside and ganglioside injection (CPCGI) versus piracetam on cognition and functional outcomes for adults with traumatic brain injury: A study protocol for randomized controlled trial – PubMed