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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-07-31

Study Completion Date

2011-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Ischemia-Reperfusion Injury Myocardial Infarction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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1

EPO

Group Type EXPERIMENTAL

Epoetin alpha

Intervention Type DRUG

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).

2

NaCl

Group Type PLACEBO_COMPARATOR

NaCl

Intervention Type DRUG

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

Interventions

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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).

Intervention Type 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.

Intervention Type DRUG

Other Intervention Names

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Eprex Sodiumchloride, saline

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Responsible Party

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University Medical Centre Groningen, Dept. of Cardiology