KCT0007235
Recruiting
未知
A phase II double-blind randomized placebo-controlled multicenter trial to assess the efficacy and safety of Neu2000KWL for out-of-hospital cardiac arrest patient with therapeutic hypothermia
ConditionsDiseases of the circulatory system
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Diseases of the circulatory system
- Sponsor
- GNT Pharma
- Enrollment
- 150
- Status
- Recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\) 19 Years to 80 Years (Adult)
- •2\) Out\-of\-hospital cardiac arrest caused by non\-perfusing cardiac rhythm
- •3\) Successful resuscitation accompanied by ROSC time of more than 20 min
- •4\) Therapeutic hypothermia is planned or initiated
- •5\) The first infusion is planned within 4 hours after ROSC
- •6\) Informed consent is obtained from patient or family member(s)
- •7\) No concern with previous cardiovascular surgery
Exclusion Criteria
- •1\) Hypersensitivity to aspirin or sulfasalazine
- •2\) Unwitnessed cardiac arrest
- •3\) CPR time \> 60 min
- •4\) Therapeutic hypothermia is not planned
- •5\) Use of extracorporeal membrane oxygenation (ECMO) at initiation of in\-hospital resuscitation (E\-CPR)
- •6\) Very poor prognosis is expected: patients with (A) non\-cardiac or respiratory arrest, (B) poor basal neurological status (C) secondary cardiac arrest caused by trauma, major bleeding, acute neurologic disease including stroke or tumor, (D) multiorgan failure or advanced malignancy
- •7\) Pregnant or lactating women
- •8\) Participated in other clinical studies within 90 days before randomization; or participating in other clinical trials at present
- •9\) Intracranial bleeding verified by first brain CT imaging
- •10\) The investigators consider the patients are not suitable for this trial
Outcomes
Primary Outcomes
Not specified
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