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Tests treatment safety and results for Butylphthalide
Official title Butylphthalide's Safety and Efficacy for Improving Neurological Function Prognosis in Patients With Cardiac Arrest (BNCA Trial)
ClinicalTrials.gov ID: NCT06353334
What this study is testing
What is Butylphthalide and Sodium Chloride Injection?
Butylphthalide and Sodium Chloride Injection is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for butylphthalide.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- Age 18-80 years old.
- GCS scores ≤8 upon admission.
- ROSC ≥30min.
- Signed the informed consent form.
You likely can't join if
- 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...
- 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.
See the full eligibility criteria
- Age 18-80 years old.
- GCS scores ≤8 upon admission.
- ROSC ≥30min.
- Signed the informed consent form.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.