Butylphthalide's Safety and Efficacy for Improving Neurological Function Prognosis in Patients With Cardiac Arrest (BNCA Trial)

NCT ID: NCT06353334

Last Updated: 2025-02-07

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-01
• Study Completion Date: 2026-12-31

Brief Summary

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.

Conditions

Butylphthalide; Cardiac Arrest; Neuroprotective Drugs

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Butylphthalide

Butylphthalide and Sodium Chloride Injection 100ml ivgtt bid 14days

Group Type: EXPERIMENTAL

Butylphthalide and Sodium Chloride Injection

Intervention Type: DRUG

All enrolled patients will undergo standard treatment as per international guidelines, concurrently receiving either NBP or placebo therapy. Patients in the experimental group will receive intravenous infusion of 100ml NBP twice daily. Each patient will receive continuous medication for 14 days.

Saline Solution

Saline Solution 100ml ivgtt bid 14days

Group Type: PLACEBO_COMPARATOR

Saline Solution

Intervention Type: DRUG

All enrolled patients will undergo standard treatment as per international guidelines, concurrently receiving either NBP or placebo therapy. Patients in the control group will receive intravenous infusion of 100ml saline solution twice daily. Each patient will receive continuous medication for 14 days.

Interventions

Butylphthalide and Sodium Chloride Injection

All enrolled patients will undergo standard treatment as per international guidelines, concurrently receiving either NBP or placebo therapy. Patients in the experimental group will receive intravenous infusion of 100ml NBP twice daily. Each patient will receive continuous medication for 14 days.

Intervention Type: DRUG

Saline Solution

All enrolled patients will undergo standard treatment as per international guidelines, concurrently receiving either NBP or placebo therapy. Patients in the control group will receive intravenous infusion of 100ml saline solution twice daily. Each patient will receive continuous medication for 14 days.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tang Ziren

OTHER

Sponsor Role: lead

Responsible Party

Tang Ziren

Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Beijing Chao-Yang Hospital

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Ziren Tang, Prof.

Role: CONTACT

tangziren1970@163.com

+86 010-85231530

Facility Contacts

Xingsheng Wang, M.D.

Role: primary

wangxingsheng1995@163.com

+86 15265386100

Other Identifiers

2024-3-22-8

Identifier Type: -

Identifier Source: org_study_id