Infusion of a Single Dose of Erythropoietin to Prevent Injury in an Ischemia Reperfusion Forearm Model (IPIIR)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00691613|
Recruitment Status : Unknown
Verified March 2010 by University Medical Center Groningen.
Recruitment status was: Not yet recruiting
First Posted : June 5, 2008
Last Update Posted : March 12, 2010
The investigators hypothesize that EPO protects against apoptosis after acute ischemia in man and that it is detectable using the annexin-A5 model.
Does infusion of a single dose of Epoetin Alfa, a short-acting EPO, protect against apoptosis in man after acute ischemia?
A double blinded randomised cross-over study.
12 Healthy male volunteers, between 18 and 40 years old.
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.
|Condition or disease||Intervention/treatment||Phase|
|Ischemia-Reperfusion Injury Myocardial Infarction||Drug: Epoetin alpha Drug: NaCl||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||12 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Primary Purpose:||Basic Science|
|Official Title:||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|
|Study Start Date :||July 2010|
|Estimated Primary Completion Date :||October 2011|
|Estimated Study Completion Date :||December 2011|
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).
Other Name: Eprex
Placebo Comparator: 2
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 Name: Sodiumchloride, saline
- 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 ]
- DNA polymorphisms affecting HO-1 and AMP-deaminase activity is assessed by DNA analysis. [ Time Frame: 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 ]
- Maximal voluntary contraction and duration of the exercise during ischemia. [ Time Frame: 10 minutes ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00691613
|Contact: W. T. Ruifrok, MD||+31 50 361 6161 ext firstname.lastname@example.org|
|Contact: R. A. de Boer, MD, PhD||+31 50 361 6161 ext email@example.com|
|Clinical Research Centre Nijmegen|
|Nijmegen, Gelderland, Netherlands, 6500 HB|
|Principal Investigator: G. A. Rongen, MD, PhD|
|Study Chair:||W. H. van Gilst, Prof, PhD||University Medical Center Groningen|
|Study Chair:||P. Smits, Prof, MD, PhD||University Medical Centre Nijmegen|
|Principal Investigator:||W. T. Ruifrok, MD||University Medical Center Groningen|
|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|