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

RecruitingPhase 4Ages 18 Years - 80 YearsAllTang Ziren
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In plain words

What the trial is, and whether it could suit you

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

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: 1. Age 18-80 years old. 2. GCS scores โ‰ค8 upon admission. 3. ROSC โ‰ฅ30min. 4. Signed the informed consent form. Exclusion Criteria: 1. Cardiac arrest due to irreversible causes such as trauma, poisoning, etc. 2. Cardiac arrest due to end-stage conditions such as advanced cancer. 3. Persistent cardiogenic shock that is unreversed (defined as a systolic blood pressure persistently \<90mmHg despite treatment with fluid resuscitation, vasopressor agents, and inotropic medications). 4. Presence of pre-existing cerebrovascular disease prior to cardiac arrest or confirmed intracranial hemorrhage by CT scan following admission. 5. Pre-existing CPC scores of 3-5 prior to cardiac arrest. 6. Prior use of NBP or any medication containing NBP before cardiac arrest. 7. Presence of severe hepatic or renal dysfunction before cardiac arrest (defined as โ‰ฅ3ร— upper limit of normal alanine transaminase or โ‰ฅ2ร— upper limit of normal creatinine). 8. Bradycardia or sick sinus syndrome occurs after ROSC. 9. History of prior drug or food allergies, or known allergies to the medication components used in this study. 10. Existence of treatment limitations (patient or their legal representative refusing advanced life support treatment, including mechanical ventilation, chest compressions, targeted temperature management, etc.). 11. Presence of severe bleeding tendency upon admission. 12. Body temperature \<30โ„ƒ upon admission. 13. Pregnant or lactating women, or reproductive-age females with elevated serum hCG levels. 14. Other conditions deemed unsuitable for this trial by the principal investigator.
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What it tests

  • Butylphthalide and Sodium Chloride Injection
  • Saline Solution
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Where

1 site
Beijing Chao-Yang Hospital
Beijing, China
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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