Abstract Number: Esoc2026ot22 Compound Porcine Cerebroside and Ganglioside Injection Versus Piracetam on Cognitive Function for Adults With Traumatic Brain Injury: A Study Protocol for Randomized Controlled Trial

Abstract Background and aims 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. Methods This study aims to determine the effectiveness and safety of CPCGI in improving cognitive and functional outcomes in TBI patients. Results 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. This study protocol is registered with the China Clinical Trial Registry (ChiCTR2000040466). Ethical approval has been granted by the ethics boards of Tianjin Medical University General Hospital and other involved institutions, adhering to the Declaration of Helsinki’s ethical guidelines. Conclusions The primary outcome is the change in the Montreal Cognitive Assessment (MoCA) score from baseline after 3 months. The main secondary outcome measures include MiniMental State Examination (MMSE) scores, Glasgow Outcome Scale-Extended (GOS-E), and the Barthel Index at 1 and 3 months. Conflict of interest