Infusion of a Single Dose of Erythropoietin to Prevent Injury in an Ischemia Reperfusion Forearm Model (IPIIR)
March 11, 2010 updated by: University Medical Center Groningen
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
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
12
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Gelderland
-
Nijmegen, Gelderland, Netherlands, 6500 HB
- Clinical Research Centre Nijmegen
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 40 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Male
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Placebo Comparator: 2
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.
Other Names:
|
|
Experimental: 1
EPO
|
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).
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
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.
Time Frame: 4 hours
|
4 hours
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
DNA polymorphisms affecting HO-1 and AMP-deaminase activity is assessed by DNA analysis.
Time Frame: 4 hours
|
4 hours
|
|
The effect of EPO treatment on heme oxygenase activity as measured in blood and as CO concentration in exhaled air.
Time Frame: 4 hours
|
4 hours
|
|
Maximal voluntary contraction and duration of the exercise during ischemia.
Time Frame: 10 minutes
|
10 minutes
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: W. T. Ruifrok, MD, University Medical Center Groningen
- Study Chair: W. H. van Gilst, Prof, PhD, University Medical Center Groningen
- Study Chair: P. Smits, Prof, MD, PhD, University Medical Centre Nijmegen
- Study Director: G. A. Rongen, MD, PhD, University Medical Centre Nijmegen
- Study Director: D.J. van Veldhuisen, Prof, MD, PhD, University Medical Center Groningen
- Principal Investigator: W. Oyen, Prof, MD, PhD, University Medical Centre Nijmegen
- Principal Investigator: R. A. de Boer, MD, PhD, University Medical Center Groningen
- Principal Investigator: P.P. van Geel, MD, PhD, University Medical Center Groningen
- Principal Investigator: R. A. Tio, MD, PhD, University Medical Center Groningen
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2010
Primary Completion (Anticipated)
October 1, 2011
Study Completion (Anticipated)
December 1, 2011
Study Registration Dates
First Submitted
June 3, 2008
First Submitted That Met QC Criteria
June 3, 2008
First Posted (Estimate)
June 5, 2008
Study Record Updates
Last Update Posted (Estimate)
March 12, 2010
Last Update Submitted That Met QC Criteria
March 11, 2010
Last Verified
March 1, 2010
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- WTR-ECG-3
- EudraCT 2007-001089-33
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