Evaluating Butylphthalide for Neurological Recovery After Cardiac Arrest

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Beijing Chao-Yang Hospital
  Beijing, Beijing Municipality, China Recruiting

Study contacts

• Study coordinator: Ziren Tang, Prof.
• Email: tangziren1970@163.com
• Phone: +86 010-85231530

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.