Infusion of a Single Dose of Erythropoietin to Prevent Injury in an Ischemia Reperfusion Forearm Model

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

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.

Inclusion Criteria:

• Healthy volunteers between 18 and 40 years of age
• male
• Volunteers are not allowed smoking 24 hours before the start of the experiment

Exclusion Criteria:

• Female
• 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