Erythropoietin and Platelet Activation Markers
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|ClinicalTrials.gov Identifier: NCT01392612|
Recruitment Status : Completed
First Posted : July 12, 2011
Last Update Posted : July 14, 2011
We hypothesized that the effect of erythropoietin may be reflected by changes in thromboxane B2 (TXB2) and endothelial cell function.
Six male and six female subjects received recombinant human epoetin alpha (Erypo®) intravenously (300 Units per kg). Biomarker levels were assessed at baseline and 4, 24, 48 and 72 hours after administration.
|Condition or disease||Intervention/treatment||Phase|
|Thrombosis Hypertension||Drug: erythropoietin||Phase 4|
Introduction: Erythropoietin (EPO) enhances formation of red blood cells and also affects thrombopoiesis and platelet function. We hypothesized that the effect of erythropoietin may be reflected by changes in thromboxane B2 (TXB2) and endothelial cell function.
Methods: Six male and six female subjects received recombinant human epoetin alpha (Erypo®) intravenously (300 Units per kg). Biomarker levels were assessed at baseline and 4, 24, 48 and 72 hours after administration.
Results: Epoetin alpha increased TXB2 levels, which reached significance at 48h (2.5- fold increase: 6.6±5ng/mL vs. 15±9ng/mL; p=0.044) and remained at that level at 72h. In line, epoetin alpha increased E-selectin levels by 25% already at 24h (39±21ng/ml vs. 49±26ng/ml; p<0.001) and stayed at this level until 72h (p<0.001). The raise in platelet activation markers corresponded with a 2-fold increase in reticulocyte count (81±17G/L vs. 43±10G/L; p<0.001) and a 9% increase in platelet count at 72h (224±45G/L vs. 244±52G/L; p=0.005). Thrombomodulin and von Willebrand factor concentrations were not significantly altered by epoetin alpha. Interestingly, gender differences in the baseline levels of E-selectin and thrombomodulin were observed. E-selectin and thrombomodulin levels were doubled in men compared to women (51±24ng/mL and 28±10ng/mL; p=0.025 and 30±5ng/mL vs. 16±5ng/mL; p=0.002, respectively).
Conclusion: Epoetin alpha increases levels of platelet activation markers. Further studies are needed to investigate whether measurement of TXB2 or E-selectin levels might be useful for estimation of thromboembolic risk during EPO-therapy.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||12 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||The Effect of Erythropoietin on Platelet Activation Markers: a Prospective Study in Healthy Volunteers|
|Study Start Date :||November 2006|
|Actual Primary Completion Date :||February 2007|
|Actual Study Completion Date :||July 2007|
all subjects received epo iv.
Subjects received one single intravenous injection of epoetin alpha (Erypo®, rhEPO, Ortho Biotech/Division of Janssen-Cilag Ag, Bridgewater, New Jersey, US) at a dose of 300 Units per kg bodyweight. Blood was sampled at baseline and 4, 24, 48 and 72 hours after administration of rhEPO during a biosimilarity trial.
Other Name: epo
- change in platelet activation markers [ Time Frame: platelet activation markers were measured 4, 24, 48 and 72 hours after administration of iv EPO ]We wanted to examine whether levels of platelet activation markers change after administration of EPO and if they do, in which time frame it happens.
- change in erythropoietin levels [ Time Frame: erythropoietin levels were measured 4, 24, 48 and 72 hours after administration ]We wanted to examine erythropoietin-levels after administration of EPO at mentioned time points.
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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01392612
|Medical University of Vienna|
|Vienna, Austria, 1090|
|Principal Investigator:||Michael Wolzt, Prof.||Medical University of Vienna|