Erythrocytosis, Erythropoiesis Abnormal
Conditions
Brief summary
In competitive sport, it is illegal to manipulate erythropoiesis. Manipulated erythropoiesis can indirectly be identified by atypical fluctuations in key haematological variables. However, this method also has limitations and as it is known that some athletes still manipulate erythropoiesis it is necessary to develop new and more sensitive detection methods. The primary purpose of the study is to examine the importance of altered erythropoiesis for surface and intracellular erythrocyte proteins, the number of immature reticulocytes, and for the haematological characteristics of the erythrocyte, such as volume, haemoglobin concentration and concentration of glycosylated haemoglobin, to assess whether these can be used to identify changed erythropoiesis. Furthermore, the aim is to examine whether these parameters are affected by freezer storage of erythrocytes.
Interventions
DRUGRecombinant human erythropoietin
Recombinant human erythropoietin treatment three times per week for three weeks
Sponsors
University of Copenhagen
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 40 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy men * 18-40 years * physical fitness rating more than 50ml/kg/min * non-smokers * blood pressure \<130/90 mmHg * hemoglobin concentration 7-10.5 mM.
Exclusion criteria
* Blood donor who has donated blood within the last three months * Participation in other concurrent clinical trials * To participate in competitive sport during or three months after the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in CD71 expression | In the period from two weeks before treatment to three weeks after treatment | Treatment induced changes in CD71 expression on red blood cells |
| Changes in CD35 expression | In the period from two weeks before treatment to three weeks after treatment | Treatment induced changes in CD35 expression on red blood cells |
| Changes in CD47 expression | In the period from two weeks before treatment to three weeks after treatment | Treatment induced changes in CD47 expression on red blood cells |
| Changes in CD55 expression | In the period from two weeks before treatment to three weeks after treatment | Treatment induced changes in CD55 expression on red blood cells |
| Changes in CD59 expression | In the period from two weeks before treatment to three weeks after treatment | Treatment induced changes in CD59 expression on red blood cells |
| Changes in RNA expression | In the period from two weeks before treatment to three weeks after treatment | Treatment induced changes in RNA expression in red blood cells |
| Changes in Mean Cell Volume | In the period from two weeks before treatment to three weeks after treatment | Treatment induced changes in Mean Cell Volume distribution of red blood cells |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in RNA cryopreserved | Cryopreserved cells are measured 6 months after sample collection | RNA expression inred blood cells before and after cryopreservation |
| Changes in Mean Cell Volume cryopreserved | Cryopreserved cells are measured 6 months after sample collection | Mean Cell Volume distribution of red blood cells before and after cryopreservation |
| Changes in Ferritin | In the period from two weeks before treatment to three weeks after treatment | Quantification of plasma ferritin concentration |
| Changes in Complete Blood Count on Advia | In the period from two weeks before treatment to three weeks after treatment | Complete Blood Count analysis on the Advia 2120i instrument |
| Changes in Complete Blood Count on Sysmex | In the period from two weeks before treatment to three weeks after treatment | Complete Blood Count analysis on the Sysmex XN-450 instrument |
| Changes in Complete Blood Count on Advia - cryopreserved | Cryopreserved cells are measured 6 months after sample collection | Complete Blood Count analysis on the Advia 2120i instrument before and after cryopreservation |
| Changes in Complete Blood Count on Sysmex - cryopreserved | Cryopreserved cells are measured 6 months after sample collection | Complete Blood Count analysis on the Sysmex XN-450 instrument before and after cryopreservation |
| Changes in HbA1c | In the period from two weeks before treatment to three weeks after treatment | Treatment induced changes in HbA1c content of red blood cells |
| Changes in CA1 | Up to 5 years | Quantification of CA1 in dried blood spots |
| Changes in SLC4a1 | Up to 5 years | Quantification of SLC4a1 in dried blood spots |
| Changes in CD71 in dried blood spots | Up to 5 years | Quantification of CD71 in dried blood spots |
| Changes in FECH | Up to 5 years | Quantification of FECH in dried blood spots |
| Changes in Band 3 | Up to 5 years | Quantification of Band 3 in dried blood spots |
| Changes in blood volume | Within 14 days before treatment and within 14 days after treatment | Measurement of blood volume by CO rebreathing |
| Changes in ALAS 2 | Up to 5 years | Quantification of ALAS 2 in dried blood spots stored at room temperature, -20C and -80C |
| Continous blood glucose levels | In the period from two weeks before treatment to three weeks after treatment | Continuous blood glucose level throughout the study |
| Changes in CD71 cryopreserved | Cryopreserved cells are measured 6 months after sample collection | CD71 expression on red blood cells before and after cryopreservation |
| Changes in CD35 cryopreserved | Cryopreserved cells are measured 6 months after sample collection | CD35 expression on red blood cells before and after cryopreservation |
| Changes in CD47 cryopreserved | Cryopreserved cells are measured 6 months after sample collection | CD47 expression on red blood cells before and after cryopreservation |
| Changes in CD55 cryopreserved | Cryopreserved cells are measured 6 months after sample collection | CD55 expression on red blood cells before and after cryopreservation |
| Changes in CD59 cryopreserved | Cryopreserved cells are measured 6 months after sample collection | CD59 expression on red blood cells before and after cryopreservation |
Countries
Denmark
Outcome results
None listed