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

Last updated: February 6, 2025
Sponsor: Tang Ziren
Overall Status: Active - Recruiting

Phase

4

Condition

Heart Attack (Myocardial Infarction)

Heart Failure

Circulation Disorders

Treatment

Butylphthalide and Sodium Chloride Injection

Saline Solution

Clinical Study ID

NCT06353334
2024-3-22-8
  • Ages 18-80
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Age 18-80 years old.

  2. GCS scores ≤8 upon admission.

  3. ROSC ≥30min.

  4. Signed the informed consent form.

Exclusion

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 bloodpressure persistently <90mmHg despite treatment with fluid resuscitation,vasopressor agents, and inotropic medications).

  4. Presence of pre-existing cerebrovascular disease prior to cardiac arrest orconfirmed 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 normalcreatinine).

  8. Bradycardia or sick sinus syndrome occurs after ROSC.

  9. History of prior drug or food allergies, or known allergies to the medicationcomponents used in this study.

  10. Existence of treatment limitations (patient or their legal representative refusingadvanced life support treatment, including mechanical ventilation, chestcompressions, 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 hCGlevels.

  14. Other conditions deemed unsuitable for this trial by the principal investigator.

Study Design

Total Participants: 100
Treatment Group(s): 2
Primary Treatment: Butylphthalide and Sodium Chloride Injection
Phase: 4
Study Start date:
September 01, 2021
Estimated Completion Date:
December 31, 2026

Connect with a study center

  • Beijing Chao-Yang Hospital

    Beijing, Beijing 100020
    China

    Active - Recruiting

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