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

Not Applicable

• Conditions: Ischemia-Reperfusion Injury; Myocardial Infarction
• Interventions: Drug: NaCl; Drug: Epoetin alpha

• Registration Number: NCT00691613
• Lead Sponsor: University Medical Center Groningen

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-06-03
• Study First Submitted QC: 2008-06-03
• Study First Posted: 2008-06-05
• Status Verified: 2010-03
• Last Update Submitted: 2010-03-11
• Last Update Posted: 2010-03-12
• Study Start: 2010-07
• Primary Completion: 2011-10
• Study Completion: 2011-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 12

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
2	NaCl	NaCl
1	Epoetin alpha	EPO

Primary Outcome Measures

Name	Time	Method
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.	4 hours

Secondary Outcome Measures

Name	Time	Method
The effect of EPO treatment on heme oxygenase activity as measured in blood and as CO concentration in exhaled air.	4 hours
DNA polymorphisms affecting HO-1 and AMP-deaminase activity is assessed by DNA analysis.	4 hours
Maximal voluntary contraction and duration of the exercise during ischemia.	10 minutes

Trial Locations

Locations (1)

Clinical Research Centre Nijmegen; 🇳🇱 Nijmegen, Gelderland, Netherlands