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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Butylphthalide | Experimental | Butylphthalide and Sodium Chloride Injection 100ml ivgtt bid 14days |
|
| Saline Solution | Placebo Comparator | Saline Solution 100ml ivgtt bid 14days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Butylphthalide and Sodium Chloride Injection | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| The proportion of patients with a CPC score of 1-2 | The primary outcome is the proportion of patients with a CPC score of 1-2 at 90days after randomization in each group. Favourable: 1 means full recovery or mild disability, 2 means moderate disability but independent in activities of daily living (ADLs). Unfavourable: 3 means severe disability-Dependent in ADLs, 4 means persistent vegetive state, 5 means Death. | 90 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ziren Tang, Prof. | Contact | +86 010-85231530 | tangziren1970@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Chao-Yang Hospital | Recruiting | Beijing | Beijing Municipality | 100020 | China |
All IPD that underlie results in a publication
Starting 6 months after publication
The de-identified survey data will be made available for research purposes by contacting the corresponding authors
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|
| Saline Solution | Drug | 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. |
|
| ID | Term |
|---|---|
| D006323 | Heart Arrest |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| C027125 | 3-n-butylphthalide |
| D012965 | Sodium Chloride |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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