Evaluating Butylphthalide for Neurological Recovery After Cardiac Arrest

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

This study is testing if a medication called Butylphthalide can help improve brain function in people who have survived a cardiac arrest.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 100 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Capital Medical University (Academic / other)
• Locations: 1 site (Beijing, Beijing Municipality)
• Trial ID: NCT06353334 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the safety and efficacy of Butylphthalide, a neuroprotective medication, in improving neurological function in patients who have experienced a cardiac arrest and achieved return of spontaneous circulation (ROSC). The study is designed as a single-center, randomized, double-blind, placebo-controlled trial involving 100 patients, who will be assigned to receive either Butylphthalide or a placebo for 14 days, starting within 6 hours of ROSC. The primary outcome will assess the proportion of patients achieving favorable neurological outcomes at 90 days post-treatment, measured by Cerebral Performance Category scores.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-80 who have achieved ROSC for at least 30 minutes and have a Glasgow Coma Scale score of 8 or less upon admission.

Not a fit: Patients with cardiac arrest due to irreversible causes, advanced cancer, or severe pre-existing conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly enhance neurological recovery in patients who survive cardiac arrest.

How similar studies have performed: While the specific application of Butylphthalide in this context is novel, previous studies on neuroprotective agents have shown promise in improving outcomes after cardiac arrest.

Eligibility criteria

Inclusion Criteria:

1. Age 18-80 years old.
2. GCS scores ≤8 upon admission.
3. ROSC ≥30min.
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 ≥3× upper limit of normal alanine transaminase or ≥2× 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 \<30℃ 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.

Where this trial is running

Beijing, Beijing Municipality

• Beijing Chao-Yang Hospital — Beijing, Beijing Municipality, China (Recruiting)

Study contacts

• Study coordinator: Ziren Tang, Prof.

Conditions Butylphthalide; Cardiac Arrest; Neuroprotective Drugs