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

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.

Conditions

• Ischemia-Reperfusion Injury
• Myocardial Infarction

Interventions

DRUG

Epoetin alpha

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).

DRUG

NaCl

0.9% sodium chloride solution as placebo dosage is 10 ml, which will be administered in the same manner as the interventional medicinal product.

Sponsors & Collaborators

• Radboud University Medical Center

  collaborator OTHER

• University Medical Center Groningen

  lead OTHER

Principal Investigators

• W. H. van Gilst, Prof, PhD · University Medical Center Groningen

• P. Smits, Prof, MD, PhD · University Medical Centre Nijmegen

• W. T. Ruifrok, MD · University Medical Center Groningen

• G. A. Rongen, MD, PhD · University Medical Centre Nijmegen

• D.J. van Veldhuisen, Prof, MD, PhD · University Medical Center Groningen

• W. Oyen, Prof, MD, PhD · University Medical Centre Nijmegen

• R. A. de Boer, MD, PhD · University Medical Center Groningen

• P.P. van Geel, MD, PhD · University Medical Center Groningen

• R. A. Tio, MD, PhD · University Medical Center Groningen

Study Design

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

TRIPLE

Model

CROSSOVER

Eligibility

Min Age

18 Years

Max Age

40 Years

Sex

MALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2010-07-31

Primary Completion

2011-10-31

Completion

2011-12-31

Countries

• Netherlands

Study Locations