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
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- The proportion of patients with a CPC score of 1-2
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-80 years old.
- •GCS scores ≤8 upon admission.
- •ROSC ≥30min.
- •Signed the informed consent form.
排除标准
- •Cardiac arrest due to irreversible causes such as trauma, poisoning, etc.
- •Cardiac arrest due to end-stage conditions such as advanced cancer.
- •Persistent cardiogenic shock that is unreversed (defined as a systolic blood pressure persistently <90mmHg despite treatment with fluid resuscitation, vasopressor agents, and inotropic medications).
- •Presence of pre-existing cerebrovascular disease prior to cardiac arrest or confirmed intracranial hemorrhage by CT scan following admission.
- •Pre-existing CPC scores of 3-5 prior to cardiac arrest.
- •Prior use of NBP or any medication containing NBP before cardiac arrest.
- •Presence of severe hepatic or renal dysfunction before cardiac arrest (defined as ≥3× upper limit of normal alanine transaminase or ≥2× upper limit of normal creatinine).
- •Bradycardia or sick sinus syndrome occurs after ROSC.
- •History of prior drug or food allergies, or known allergies to the medication components used in this study.
- •Existence of treatment limitations (patient or their legal representative refusing advanced life support treatment, including mechanical ventilation, chest compressions, targeted temperature management, etc.).
- •Presence of severe bleeding tendency upon admission.
- •Body temperature <30℃ upon admission.
- •Pregnant or lactating women, or reproductive-age females with elevated serum hCG levels.
- •Other conditions deemed unsuitable for this trial by the principal investigator.
研究组 & 干预措施
Butylphthalide
Butylphthalide and Sodium Chloride Injection 100ml ivgtt bid 14days
干预措施: Butylphthalide and Sodium Chloride Injection (Drug)
Saline Solution
Saline Solution 100ml ivgtt bid 14days
干预措施: Saline Solution (Drug)
结局指标
主要结局
The proportion of patients with a CPC score of 1-2
时间窗: 90 days
The primary outcome is the proportion of patients with a CPC score of 1-2 at 90days after randomization in each group. Favourable: 1 means full recovery or mild disability, 2 means moderate disability but independent in activities of daily living (ADLs). Unfavourable: 3 means severe disability-Dependent in ADLs, 4 means persistent vegetive state, 5 means Death.
次要结局
未报告次要终点
研究者
Tang Ziren
Professor
Capital Medical University