NCT00691613

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 12 (estimated)
• Sponsor: University Medical Center Groningen · Academic / Other
• Sex: Male
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2010-07-01
• Primary completion: 2011-10-01
• Completion: 2011-12-01
• First posted: 2008-06-05
• Last updated: 2010-03-12

Locations

1 site across 1 country: Netherlands