A Phase II, Double-blind, Randomized, Placebo-controlled, Multicenter Trial to Assess the Efficacy and Safety of Neu2000KWL in Patients Who Resuscitated After Out-of-hospital Cardiac Arrest Patient and Receiving Therapeutic Hypothermia
试验速览
- 阶段
- 2 期
- 发起方
- GNT Pharma
- 入组人数
- 150
- 试验地点
- 6
- 主要终点
- Verification of difference between of Neuron specific enolase (NSE) value at after 4th infusion of Neu2000KWL.
研究概览
简要总结
This study aims to investigate the efficacy and safety of Neu2000KWL, a neuroprotectant, in patients resuscitated from out-of-hospital cardiac arrest and receiving therapeutic hypothermia.
详细描述
Lack of good neurological recovery is the biggest hurdle in the treatment of out-of-hospital cardia arrest. Neu2000KWL, a N-Methyl-D-aspartate (NMDA) receptor antagonist and an antioxidant, attenuated cerebral neuronal death and reduced hypoxic injury of brain in preclinical studies. Phase I clinical study has revealed that Neu2000KWL is very safe for treating human. In current study, the investigators will assess the efficacy of Neu2000KWL to compare the neurological biomarker, brain imaging, and clinical outcomes of patients successfully resuscitated from out-of-cardiac arrest treated by 3-day infusion of Neu2000KWL with patients assigned to placebo arm.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
盲法说明
Double Blind (Subject, Caregiver, Investigator)
入排标准
- 年龄范围
- 19 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •19 Years to 80 Years (Adult)
- •Out-of-hospital cardiac arrest caused by non-perfusing cardiac rhythm
- •Successful resuscitation accompanied by ROSC time of more than 20 min
- •Therapeutic hypothermia is planned or initiated
- •The first infusion is planned within 4 hours after ROSC
- •Informed consent is obtained from patient or family member(s)
- •No concern with previous cardiovascular surgery
排除标准
- •Hypersensitivity to aspirin or sulfasalazine
- •Unwitnessed cardiac arrest
- •CPR time > 60 min
- •Therapeutic hypothermia is not planned
- •Use of extracorporeal membrane oxygenation (ECMO) at initiation of in-hospital resuscitation (E-CPR)
- •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
- •Pregnant or lactating women
- •Participated in other clinical studies within 90 days before randomization; or participating in other clinical trials at present
- •Intracranial bleeding verified by first brain CT imaging
- •The investigators consider the patients are not suitable for this trial
研究组 & 干预措施
Neu2000KWL high dose
干预措施: Neu2000KWL High-dose group (Drug)
Neu2000KWL low dose
干预措施: Neu2000KWL Low-dose group (Drug)
saline
干预措施: Placebo (Drug)
结局指标
主要结局
Verification of difference between of Neuron specific enolase (NSE) value at after 4th infusion of Neu2000KWL.
时间窗: The 3rd day of study (which corresponds to finished 4th infusion of Neu2000KWL).
Blood concentration of neuron specific enolase (NSE)
次要结局
- Verification of the difference between groups of Change in NSE values at after the 2nd infusion of Neu2000KWL and after the 6th infusion(At the 24 hours and 72 hours after the first infusion of Neu2000KWL.)
- Verification of difference between the cumulative of neuron specific enolase (NSE) values at after 6th infusion of Neu2000KWL(The 4th day of study (which corresponds to finished 6th infusion of Neu2000KWL).)
- Verification of difference between groups of Cumulative value of blood S100beta from 6th infusion after 1st infusion of Neu2000KWL.(The 4th day of study (which corresponds to finished 6th infusion of Neu2000KWL).)
- Verification of difference between each group of NSE values at after 6th infusion after 1st infusion of Neu2000KWL and 24 hours after end of last infusion(The 4th and 5th day of study (which corresponds to the timepoint of finished treatment using Neu2000KWL and 24 hour after finished treatment using Neu2000KWL).)
- Verification of difference between the cerebral infarction at analysis of brain MRI's Apparent Diffusion Coefficient(ADC) images within 48 hours of the last infusion of Neu2000KWL(The 5th day of study (which corresponds to 48 hours after finished treatment using Neu2000KWL).)
- Verification of difference between groups of Neurological function evaluated by cerebral performance category (CPC) and modified Rankin Scale (mRS) at 5 day, 14 day, or discharge within 14 days, and 90 days after 1st infusion of Neu2000KWL.(5 day, 14 day, or discharge within 14 days, and 90 days after 1st infusion of Neu2000KWL)