NCT06353334

Butylphthalide's Safety and Efficacy for Improving Neurological Function Prognosis in Patients With Cardiac Arrest (BNCA Trial)

Butylphthalide's Safety and Efficacy for Improving Neurological Function Prognosis in Patients With Cardiac Arrest (BNCA Trial): A Single-Center, Randomized, Double-Blind, Placebo-Controlled Study

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Tang Ziren · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

Butylphthalide (NBP) is a neuroprotective medication capable of ameliorating neurological dysfunction induced by ischemia, hypoxia, and reperfusion injury in the brain. However, evidence regarding the improvement of neurological function prognosis in patients with return of spontaneous circulation (ROSC) after cardiac arrest (CA) by NBP is limited. This study aims to evaluate the safety and efficacy of NBP treatment in improving the neurological function prognosis of patients with ROSC after CA.The study will be a single-center, randomized, double-blind, placebo-controlled trial. The sample size is estimated to be 100 patients. Eligible patients will be randomly allocated in a 1:1 ratio to receive either NBP or placebo treatment daily for a duration of 14 days. The initial administration of NBP or placebo treatment will commence within 6 hours after ROSC following CA. The primary outcome is the proportion of patients with Cerebral Performance Category (CPC) scores of 1-2 at 90 days after randomization in each group. The primary safety outcome is the percentage of severe adverse events occurring during the 14-day treatment period. This trial will determine the efficacy of NBP in providing neuroprotective effects for patients with ROSC after CA.

Conditions

• Butylphthalide
• Cardiac Arrest
• Neuroprotective Drugs

Interventions

Type	Name	Description
DRUG	Butylphthalide and Sodium Chloride Injection	All enrolled patients will undergo standard treatment as per international guidelines, concurrently receiving either NBP or placebo therapy. Patients in the experimental group will receive intravenous infusion of 100ml NBP twice daily. Each patient will receive continuous medication for 14 days.
DRUG	Saline Solution	All enrolled patients will undergo standard treatment as per international guidelines, concurrently receiving either NBP or placebo therapy. Patients in the control group will receive intravenous infusion of 100ml saline solution twice daily. Each patient will receive continuous medication for 14 days.

Timeline

• Start date: 2021-09-01
• Primary completion: 2026-12-31
• Completion: 2026-12-31
• First posted: 2024-04-09
• Last updated: 2025-02-07

Locations

1 site across 1 country: China