Infusion of a Single Dose of Erythropoietin to Prevent Injury in an Ischemia Reperfusion Forearm Model - A Randomised Cross-over Study to Evaluate if Infusion of a Single Dose of EPO Protects Against Ischemia-reperfusion Injury in Man
试验速览
- 阶段
- 不适用
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- The percentage of difference between radioactivity (quantified as counts per pixel) of the predefined area of interest of the experimental and control thenar muscle at one and four hours after reperfusion.
研究概览
简要总结
Rationale:
The investigators hypothesize that EPO protects against apoptosis after acute ischemia in man and that it is detectable using the annexin-A5 model.
Objective:
Does infusion of a single dose of Epoetin Alfa, a short-acting EPO, protect against apoptosis in man after acute ischemia?
Study design:
A double blinded randomised cross-over study.
Study population:
12 Healthy male volunteers, between 18 and 40 years old.
Intervention:
All 12 volunteers will receive a single dose of EPO and placebo in a randomized order. A six week wash-out period is obtained in order to avoid interference of both treatments.
Main study parameters/endpoints:
The percentage of difference between radioactivity (quantified as counts per pixel) of the experimental and control thenar muscle at one and four hours after reperfusion.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy volunteers between 18 and 40 years of age
- •Volunteers are not allowed smoking 24 hours before the start of the experiment
排除标准
- •Hypertension (SBP >140 mmHg, DBP >90 mmHg)
- •Diabetes Mellitus (DM) (fasting glc >6.9 mmol/l, glc >11.0 mmol/l)
- •Hypercholesterolemia
- •Renal dysfunction (eGFR < 60 ml/min, calculated using MDRD formula)
- •Any known hypersensitivity/allergic reaction to one of the constituents of Epoetin Alfa
- •A history of use of any form of EPO
- •Any current medication use
- •Cardiovascular disease in medical history
- •Smoking less than 24 hours prior to Epoetin alpha infusion
- •Participation in research in the last 5 years in which any form of radioactivity was used
- •No participation in any research trial in the last 30 days or 5 times the half-life of the used substance
研究组 & 干预措施
2
NaCl
干预措施: NaCl (Drug)
1
EPO
干预措施: Epoetin alpha (Drug)
结局指标
主要结局
The percentage of difference between radioactivity (quantified as counts per pixel) of the predefined area of interest of the experimental and control thenar muscle at one and four hours after reperfusion.
时间窗: 4 hours
次要结局
- The effect of EPO treatment on heme oxygenase activity as measured in blood and as CO concentration in exhaled air.(4 hours)
- DNA polymorphisms affecting HO-1 and AMP-deaminase activity is assessed by DNA analysis.(4 hours)
- Maximal voluntary contraction and duration of the exercise during ischemia.(10 minutes)