BRIDGE - Blocking Receptor of IL-1β for Donor Graft Edema Reduction
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Primary graft dysfunction after lung transplant
研究概览
简要总结
This study will determine if primary graft dysfunction (which causes low blood oxygen levels and fluid or inflammation in the lungs) after lung transplant can be prevented through the use of the study drug (IL-1 receptor antagonist, Anakinra). In this study, lung transplant participants who are randomized to the treatment group will have the study drug injected into the solution that their donor lungs are kept in prior to transplant.
详细描述
After being informed about the study and potential risks, all patients giving written consent who undergo a lung transplant will be randomized in a 1:1 ratio to either the treatment or control group. Patients randomized to the treatment group will have one dose of the study drug, Anakinra, injected into the perfusion solution that their donor lungs are kept in just prior to lung transplant. Both groups will receive standard lung transplant care after implantation.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 years or older.
- •Planning to undergo transplantation of the lung.
- •Willing and able to read, understand, and be capable of giving informed consent.
- •Use of ex vivo lung perfusion (EVLP) prior to lung transplant.
排除标准
- •Previous or current use of IL-1R antagonist drug.
- •Any condition that, in the opinion of the attending physician, would place the patient at undue risk by participating, such as highly sensitized patients who require additional immunosuppression, multiorgan transplant, and re- transplant.
研究组 & 干预措施
Control group
Control group will not receive Anakinra during EVLP.
Treatment group: Anakinra during EVLP
One dose (100mg) Anakinra will be injected into the perfusion solution during ex vivo lung perfusion (EVLP) prior to lung transplant.
干预措施: Anakinra (Drug)
结局指标
主要结局
Primary graft dysfunction after lung transplant
时间窗: 3 days post lung transplant
Occurrence of primary graft dysfunction after lung transplant on post-operative day 3, measured by arterial blood gas blood tests and chest X-rays.
次要结局
- Length of ICU stay post lung transplant, assessed up to one year post transplant(Days post lung transplant up to 52 weeks)
- Length of hospital stay post lung transplant, assessed up to one year post transplant(Days post lung transplant up to 52 weeks)
- Length of ventilator use post lung transplant, assessed up to one year post transplant(Days post lung transplant up to 52 weeks)
- Survival after lung transplant(30 days, 90 days and one year post lung transplant)
研究者
Chitaru Kurihara
Assistant Professor of Surgery
Northwestern University