[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"butylphthalide\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:butylphthalide":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,43],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100560049","phase-4-neuroprotective-effect-of-butylphthalide-for-cardiac-arrest-patients-100560049",false,"NCT06572085","Neuroprotective Effect of Butylphthalide for Cardiac Arrest Patients","Neuroprotective Effect of Butylphthalide Injection on Patients With Return of Spontaneous Circulation After Cardiac Arrest：a Multicenter, Randomized Clinical Trial","Inclusion Criteria:\n\n1. Age 18-80 years old.\n2. Glasgow Coma Scale (GCS) scores ≤8 upon admission.\n3. Return of Spontaneous Circulation (ROSC) ≥30min.\n4. Signed the informed consent form.\n\nExclusion Criteria:\n\n1. Cardiac arrest due to irreversible causes such as trauma, poisoning, etc.\n2. Cardiac arrest due to end-stage conditions such as advanced cancer.\n3. Persistent cardiogenic shock that is unreversed (defined as a systolic blood pressure persistently \\\u003C90mmHg despite treatment with fluid resuscitation, vasopressor agents, and inotropic medications).\n4. Presence of pre-existing cerebrovascular disease prior to cardiac arrest or confirmed intracranial hemorrhage by CT scan following admission.\n5. Pre-existing CPC scores of 3-5 prior to cardiac arrest.\n6. Prior use of NBP or any medication containing NBP before cardiac arrest.\n7. 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).\n8. Bradycardia or sick sinus syndrome occurs after ROSC.\n9. History of prior drug or food allergies, or known allergies to the medication components used in this study.\n10. Existence of treatment limitations (patient or their legal representative refusing advanced life support treatment, including mechanical ventilation, chest compressions, targeted temperature management, etc.).\n11. Presence of severe bleeding tendency upon admission.\n12. Body temperature \\\u003C30℃ upon admission.\n13. Pregnant or lactating women, or reproductive-age females with elevated serum human Chorionic Gonadotropin (hCG) levels.\n14. Other conditions deemed unsuitable for this trial by the principal investigator.","ALL","18 Years","80 Years",{"count":20,"type":21},350,"ESTIMATED","INTERVENTIONAL",[24],"PHASE4","Cardiac arrest is one of the critical illnesses that is directly life-threatening, and patients who survive cardiac arrest develop severe neurological deficits or even die. The effectiveness of drugs to improve neurological function in resuscitated brain-injured patients has been a focus of research in the field of resuscitation. Butanephthalein has an ameliorating effect on the damage of central nervous function in patients with acute ischemic stroke, and can promote the improvement of patients' neurological deficits. On this basis, the present study was designed as a multicenter, prospective randomized controlled experiment, with internationally accepted methods for assessing near-term and long-term neurological function, to determine the effectiveness of butalbital in improving neurological function after cardiac arrest, with the aim of searching for new methods and ideas to improve neurological function and prognosis after cardiac arrest.",[27,28,29],"Butylphthalide","Cardiac Arrest","Neuroprotective Drugs","RECRUITING","2025-04-10",{"date":33,"type":34},"2025-04-11","ACTUAL",{"date":36,"type":34},"2022-01-01",{"date":38,"type":21},"2027-12-31",{"name":40,"class":41},"Tang Ziren","OTHER",1,{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":4,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":50,"targetDuration":4,"studyType":22,"phases":52,"briefSummary":53,"conditions":54,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":55,"lastUpdatePostDateStruct":56,"startDateStruct":58,"completionDateStruct":60,"leadSponsor":62,"locationsCount":42},"100543243","phase-4-butylphthalides-safety-and-efficacy-for-improving-neurological-function-prognosis-in-patients-with-cardiac-arrest-bnca-trial-100543243","NCT06353334","Butylphthalide's Safety and Efficacy for Improving Neurological Function Prognosis in Patients With Cardiac Arrest (BNCA Trial)","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","Inclusion Criteria:\n\n1. Age 18-80 years old.\n2. GCS scores ≤8 upon admission.\n3. ROSC ≥30min.\n4. Signed the informed consent form.\n\nExclusion Criteria:\n\n1. Cardiac arrest due to irreversible causes such as trauma, poisoning, etc.\n2. Cardiac arrest due to end-stage conditions such as advanced cancer.\n3. Persistent cardiogenic shock that is unreversed (defined as a systolic blood pressure persistently \\\u003C90mmHg despite treatment with fluid resuscitation, vasopressor agents, and inotropic medications).\n4. Presence of pre-existing cerebrovascular disease prior to cardiac arrest or confirmed intracranial hemorrhage by CT scan following admission.\n5. Pre-existing CPC scores of 3-5 prior to cardiac arrest.\n6. Prior use of NBP or any medication containing NBP before cardiac arrest.\n7. 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).\n8. Bradycardia or sick sinus syndrome occurs after ROSC.\n9. History of prior drug or food allergies, or known allergies to the medication components used in this study.\n10. Existence of treatment limitations (patient or their legal representative refusing advanced life support treatment, including mechanical ventilation, chest compressions, targeted temperature management, etc.).\n11. Presence of severe bleeding tendency upon admission.\n12. Body temperature \\\u003C30℃ upon admission.\n13. Pregnant or lactating women, or reproductive-age females with elevated serum hCG levels.\n14. Other conditions deemed unsuitable for this trial by the principal investigator.",{"count":51,"type":21},100,[24],"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.",[27,28,29],"2025-02-06",{"date":57,"type":34},"2025-02-07",{"date":59,"type":34},"2021-09-01",{"date":61,"type":21},"2026-12-31",{"name":40,"class":41}]