Actively Recruiting
Butylphthalide's Safety and Efficacy for Improving Neurological Function Prognosis in Patients With Cardiac Arrest (BNCA Trial)
Led by Tang Ziren · Updated on 2025-02-07
100
Participants Needed
1
Research Sites
278 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Butylphthalide's Safety and Efficacy for Improving Neurological Function Prognosis in Patients With Cardiac Arrest (BNCA Trial)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18-80 years old
- Glasgow Coma Scale score of 8 or below upon admission
- Return of spontaneous circulation lasting 30 minutes or more
- Signed informed consent form
You will not qualify if you...
- Cardiac arrest caused by irreversible conditions like trauma or poisoning
- Cardiac arrest due to end-stage illnesses such as advanced cancer
- Ongoing cardiogenic shock with low blood pressure despite treatment
- Pre-existing cerebrovascular disease or confirmed brain bleeding after admission
- Pre-existing poor cerebral performance scores before cardiac arrest
- Previous use of Butylphthalide or related medications before cardiac arrest
- Severe liver or kidney dysfunction before cardiac arrest
- Bradycardia or sick sinus syndrome after return of spontaneous circulation
- History of drug or food allergies or allergies to study medications
- Limitations on advanced life support treatments requested
- Severe bleeding issues upon admission
- Body temperature below 30°C upon admission
- Pregnant or breastfeeding women or women with elevated pregnancy hormone levels
- Any other conditions the principal investigator considers unsuitable for the trial
AI-Screening
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Trial Site Locations
Total: 1 location
1
Beijing Chao-Yang Hospital
Beijing, Beijing Municipality, China, 100020
Actively Recruiting
Research Team
Z
Ziren Tang, Prof.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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