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
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• Age 18-80 years old.

• GCS scores ≤8 upon admission.

• ROSC ≥30min.

• Signed the informed consent form.

Locations
Other Locations
China
Beijing Chao-Yang Hospital
RECRUITING
Beijing
Contact Information
Primary
Ziren Tang, Prof.
tangziren1970@163.com
+86 010-85231530
Time Frame
Start Date: 2021-09-01
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 100
Treatments
Experimental: Butylphthalide
Butylphthalide and Sodium Chloride Injection 100ml ivgtt bid 14days
Placebo_comparator: Saline Solution
Saline Solution 100ml ivgtt bid 14days
Related Therapeutic Areas
Sponsors
Leads: Tang Ziren

This content was sourced from clinicaltrials.gov