Actively Recruiting
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
Led by Tang Ziren · Updated on 2025-02-07
100
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the potential benefits of Butylphthalide (NBP), a neuroprotective drug, in improving neurological outcomes for patients who have experienced cardiac arrest and have regained spontaneous circulation (ROSC). The trial aims to evaluate the safety and effectiveness of NBP in reducing brain injury caused by lack of oxygen and blood flow after cardiac arrest. This is a randomized, double-blind, placebo-controlled study conducted at a single center. Participants will be randomly assigned to receive either an intravenous infusion of Butylphthalide combined with sodium chloride or a saline placebo. Both treatments are given twice daily for 14 days, starting within 6 hours after ROSC. All patients will also receive standard care according to international guidelines during the study. The study groups are compared to assess NBP's neuroprotective effects. During the study, participants will be monitored closely for neurological function using the Cerebral Performance Category (CPC) score at 90 days after treatment begins. Safety will be tracked by recording any severe adverse events during the 14-day treatment period. The trial involves regular evaluations to ensure participant safety and to measure the drug's impact on brain recovery following cardiac arrest.
CONDITIONS
Brief 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 between 18 and 80 years old
- Glasgow Coma Scale (GCS) score of 8 or less upon admission
- Return of spontaneous circulation (ROSC) lasting 30 minutes or more
- Signed informed consent form
You will not qualify if you...
- Cardiac arrest caused by irreversible events like trauma or poisoning
- Cardiac arrest due to end-stage illnesses such as advanced cancer
- Persistent cardiogenic shock unresponsive to treatment (systolic blood pressure below 90 mmHg)
- Pre-existing cerebrovascular disease or confirmed brain bleeding after admission
- Pre-existing Cerebral Performance Category (CPC) scores of 3 to 5 before cardiac arrest
- Prior use of Butylphthalide or related medications before cardiac arrest
- Severe liver or kidney dysfunction before cardiac arrest
- Bradycardia or sick sinus syndrome after ROSC
- History of allergies to study medications or their components
- Refusal of advanced life support treatments by patient or legal representative
- Severe bleeding tendency upon admission
- Body temperature below 30°C upon admission
- Pregnant or breastfeeding women, or women with elevated pregnancy hormone levels
- Any other condition deemed unsuitable by the principal investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
screening and enrollment visit
Duration - 14 days
Participants receive intravenous infusion of either Butylphthalide or saline solution twice daily alongside standard treatment.
Daily visits or monitoring during treatment
Trial Site Locations
Total: 1 location
1
Beijing Chao-Yang Hospital
Beijing, Beijing Municipality, China, 100020
Actively Recruiting
Research Team
Z
Ziren Tang, Prof.
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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