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Recruiting NCT06353334

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

Phase IV Interventional Butylphthalide Cardiac Arrest Neuroprotective Drugs

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Butylphthalide and Sodium Chloride Injection, Saline Solution.
Who it may be relevant to
Registry conditions: Butylphthalide, Cardiac Arrest, Neuroprotective Drugs. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Butylphthalide's Safety and Efficacy for Improving Neurological Function Prognosis in Patients With Cardiac Arrest (BNCA Trial): A Single-Center, Randomized, Double-Blind, Placebo-Controlled Study

Overview

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.

Interventions

  • Drug 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.
  • 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.

Primary outcome measures

  • The proportion of patients with a CPC score of 1-2 [Time frame: 90 days]

Eligibility criteria

Inclusion criteria

  • Age 18-80 years old.
  • GCS scores ≤8 upon admission.
  • ROSC ≥30min.
  • Signed the informed consent form.

Exclusion criteria

  • Cardiac arrest due to irreversible causes such as trauma, poisoning, etc.
  • Cardiac arrest due to end-stage conditions such as advanced cancer.
  • Persistent cardiogenic shock that is unreversed (defined as a systolic blood pressure persistently <90mmHg despite treatment with fluid resuscitation, vasopressor agents, and inotropic medications).
  • Presence of pre-existing cerebrovascular disease prior to cardiac arrest or confirmed intracranial hemorrhage by CT scan following admission.
  • Pre-existing CPC scores of 3-5 prior to cardiac arrest.
  • Prior use of NBP or any medication containing NBP before cardiac arrest.
  • 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).
  • Bradycardia or sick sinus syndrome occurs after ROSC.
  • History of prior drug or food allergies, or known allergies to the medication components used in this study.
  • Existence of treatment limitations (patient or their legal representative refusing advanced life support treatment, including mechanical ventilation, chest compressions, targeted temperature management, etc.).
  • Presence of severe bleeding tendency upon admission.
  • Body temperature <30℃ upon admission.
  • Pregnant or lactating women, or reproductive-age females with elevated serum hCG levels.
  • Other conditions deemed unsuitable for this trial by the principal investigator.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

China · 1 center
  • Beijing Chao-Yang Hospital — Beijing

Identifiers

NCT: NCT06353334 · 2024-3-22-8

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗