Butylphthalide for improving brain function after cardiac arrest

Neuroprotective Effect of Butylphthalide Injection on Patients With Return of Spontaneous Circulation After Cardiac Arrest：a Multicenter, Randomized Clinical Trial

This study is testing if butylphthalide can help improve brain function in people who have survived cardiac arrest.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 350 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Capital Medical University (Academic / other)
• Locations: 1 site (Beijing, Beijing Municipality)
• Trial ID: NCT06572085 on ClinicalTrials.gov

What this trial studies

This study investigates the neuroprotective effects of butylphthalide in patients who have experienced cardiac arrest. It is a multicenter, prospective randomized controlled trial designed to assess both near-term and long-term neurological outcomes in patients with severe brain injury following resuscitation. Participants will receive either butylphthalide or a saline solution, and their neurological function will be evaluated using internationally accepted assessment methods. The goal is to find effective treatments to enhance recovery and improve prognosis for these patients.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-80 with a Glasgow Coma Scale score of 8 or lower upon admission who have achieved return of spontaneous circulation for at least 30 minutes.

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

Why it matters

Potential benefit: If successful, this treatment could significantly improve neurological recovery and quality of life for cardiac arrest survivors.

How similar studies have performed: While there have been studies on neuroprotective drugs in stroke patients, the specific use of butylphthalide in cardiac arrest is a novel approach.

Eligibility criteria

Inclusion Criteria:

1. Age 18-80 years old.
2. Glasgow Coma Scale (GCS) scores ≤8 upon admission.
3. Return of Spontaneous Circulation (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 human Chorionic Gonadotropin (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, Ph.D

Conditions Butylphthalide; Cardiac Arrest; Neuroprotective Drugs