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

• Status: Unknown status
• Trial end date: 2011-12-01
• Target enrollment: 0
• Participant gender: Male

Summary

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.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University Medical Center Groningen
• Collaborator: Radboud University
• Treatments: Epoetin Alfa

Criteria

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