Butylphthalide for improving brain function after cardiac arrest
Official title: Neuroprotective Effect of Butylphthalide Injection on Patients With Return of Spontaneous Circulation After Cardiac Arrest:a Multicenter, Randomized Clinical Trial
Run by Capital Medical University · NCT06572085 · Data updated 2026-11-12
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 |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Enrollment | 350 (estimated) |
| Sponsor | Capital Medical University Academic / other |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Status | Recruiting |
| Started | January 1, 2022 |
| Main results expected | December 31, 2027 |
| Study ends | December 31, 2027 |
| Registry record updated | April 11, 2025 |
| Trial ID | NCT06572085 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably not a fit
Patients with irreversible causes of cardiac arrest, advanced cancer, or severe pre-existing conditions may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: While there have been studies on neuroprotective drugs in stroke patients, the specific use of butylphthalide in cardiac arrest is a novel approach.
Who can join: the full rules
Show full inclusion / exclusion 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 it's running
-
Beijing Chao-Yang Hospital
Beijing, Beijing Municipality, China Recruiting
Study contacts
- Study coordinator: Ziren Tang, Ph.D
- Email: tangziren1970@163.com
- Phone: +86 010-85231530
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Evaluating Butylphthalide for Neurological Recovery After Cardiac Arrest
This study is testing if a medication called Butylphthalide can help improve brain function in people who have survived a cardiac arrest.
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We will test whether adding a digital serious game to regular lectures helps adult ICU nurses learn targeted temperature management and improve situational awareness.
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Plasma proteins, metabolites, and platelet changes in extracorporeal CPR for cardiac arrest patients
This project will test whether patterns in blood proteins, small molecules, and platelet shape changes can help identify which adults with cardiac arrest might benefit from extracorporeal CPR.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.