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

University Medical Center Groningen (UMCG)

Status: Unknown

Conditions: Ischemia-Reperfusion Injury; Myocardial Infarction

Treatments: Drug: Epoetin alpha; Drug: NaCl

Study type: Interventional

Funder types: Other

Identifiers

NCT00691613

WTR-ECG-3

EudraCT 2007-001089-33

Details and patient eligibility

About

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.

Enrollment: 12 estimated patients

Sex: Male

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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12 participants in 2 patient groups, including a placebo group

1

Experimental group

Description:

EPO

Treatment:

Drug: Epoetin alpha

2

Placebo Comparator group

Description:

NaCl

Treatment:

Drug: NaCl