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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Enrollment
12
The dosage (60.000 I/U Epoetin alpha) will be diluted in 10 ml of 0.9% sodium chloride solution and injected in a single dose intravenously in the dominant forearm (the non-dominant forearm will be used as ischemic model).
0.9% sodium chloride solution as placebo dosage is 10 ml, which will be administered in the same manner as the interventional medicinal product.
Clinical Research Centre Nijmegen
Nijmegen, Gelderland, Netherlands
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.
Time frame: 4 hours
DNA polymorphisms affecting HO-1 and AMP-deaminase activity is assessed by DNA analysis.
Time frame: 4 hours
The effect of EPO treatment on heme oxygenase activity as measured in blood and as CO concentration in exhaled air.
Time frame: 4 hours
Maximal voluntary contraction and duration of the exercise during ischemia.
Time frame: 10 minutes
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