Impact of CErebral Endovascular PROcedures on the Systemic Immune responSe Response
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 78
- 试验地点
- 2
- 主要终点
- Change in blood concentrations of cytokines of the innate immune response
研究概览
简要总结
In our ICU, it could notice that patients with cerebral arterio-venous malformation (AVM) treated with embolization develop more severe Ventilator Associated Pneumoniae (VAP) compare to other patients hospitalized for neurological diseases. The Dimethylsulfoxyde (DMSO), the solvent of the embolization implant, is known to have immune effect on vitro analysis. The investigator want to prove that exposition to embolization implant for a cerebral AMV modify the cytokines production involved the system immune's regulation.
详细描述
Cerebral AVM are defined by abnormal connections between arteries and veins. For treatment of this vascular malformation, embolization is the gold standard. Embolization agent is made with vinylic alcohol ethylene (EVOH) copolymer which (the embolization implant) and the DMSO which is the solvent. During the injection of the product, DMSO dissipates in the bloodstream, and the EVOH precipitates and forms the embolus. It knows that DMSO had in-vitro immune effect (inhibits signalizations ways of innate and acquired immune response, decrease of pro-inflammatory cytokines production and decrease INF-γ and TNF-α production). DMSO could decrease activation and recruitment of leukocytes, which could expose patients to an increased risk of infection.
The investigator will dose cytokines in 3 blood samples (preoperative, H+6 and H+24) in planned patient's hospitalized for cerebral AVM embolization. The cytokine content of the plasmas will be analyzed with multiplex ELISA technic
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 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
- •Adult hospitalized for a planned cerebral embolization
排除标准
- •Immunosuppressed patient or immunosuppressive treatment (corticosteroid included)
- •Patient with auto-immune disease
- •Hospitalization in ICU or for a planned or emergency surgery in the past three months
- •Hospitalization for an active infection in the past three months
- •Pregnancy
- •Patients requiring steroid therapy to prevent postoperative nausea and/or vomiting
研究组 & 干预措施
cerebral AVM embolization
干预措施: Blood sample (Other)
cerebral aneurism embolization
干预措施: Blood sample (Other)
结局指标
主要结局
Change in blood concentrations of cytokines of the innate immune response
时间窗: Hour 0 and Hour 6
Compare blood concentrations of cytokines (IL-1N, IL-10, IL-12p70, IL-6, IL-2, IL-4, IL-17A; TNF-a, TGF-b1, IFN-g) of the innate immune response between patients who underwent a cerebral AVM embolization procedure with patients who underwent a cerebral aneurysm embolization procedure between the expected peak at H6 and H0
次要结局
- blood concentrations of cytokines according to the volume of embolizing agent(Hour 0 and Hour 6)
- blood concentrations of cytokines of adaptive and innate immune response(Hour 0 and Hour 24)
- blood concentrations of cytokines(Hour 6)
- blood concentrations of cytokines of adaptive immune response(Hour 0 and Hour 6)
- Cortisol production(Hour 0 and Hour 6)
- lymphocyte subpopulations differences(Hour 24 and Hour 0)
- blood concentrations of cytokines according to the embolizing agent(Hour 0 and Hour 6)