A Phase 4 interventional study of Butylphthalide and Sodium Chloride Injection and Saline Solution in Butylphthalide, Cardiac Arrest and Neuroprotective Drugs, sponsored by Tang Ziren. Recruiting at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-04-11.
Sponsored by Tang Ziren · Phase 4, Interventional, and Treatment
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.
966 studies on the registry are indexed under Heart Arrest; 227 are open to participants now.
This study's planned enrollment of 350 is above the median of 100 across 557 interventional studies indexed under Heart Arrest.
Browse Heart Arrest studies →Tang Ziren is the lead sponsor of 7 studies on the registry; 5 are open to participants now.
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Exclusion Criteria:
Butylphthalide and Sodium Chloride Injection 100ml ivgtt bid 14days
Drug: Butylphthalide and Sodium Chloride Injection
Saline Solution 100ml ivgtt bid 14days
Drug: Saline Solution
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 injection twice daily, while patients in the control group will receive intravenous infusion of 100ml saline solution twice daily. Each patient will receive continuous medication for 14 days.
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 injection twice daily, while patients in the control group will receive intravenous infusion of 100ml saline solution twice daily. Each patient will receive continuous medication for 14 days.
The proportion of patients with a Cerebral Performance Category (CPC) Score of 1-2
The primary outcome is the proportion of patients with a Cerebral Performance Category (CPC) score of 1-2 at 6months after randomization in each group.
Time frame: 6 months
Plan to share: Yes — All IPD that underlie results in a publication
Supporting information: Study protocol, Sap, Icf, Csr
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