Erythropoietin and Platelet Activation Markers

NCT01392612 | Completed Phase 4 DMC

• 1 other identifier: EPO1
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Thrombosis; Hypertension

Keywords

thrombosis; hypertension; gender; endothelium

Outcome Measures

Primary Outcomes (1)

• change in platelet activation markers

  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.

  platelet activation markers were measured 4, 24, 48 and 72 hours after administration of iv EPO

Secondary Outcomes (1)

• change in erythropoietin levels

  erythropoietin levels were measured 4, 24, 48 and 72 hours after administration

Study Arms (1)

Erythropoietin

OTHER

all subjects received epo iv.

Drug: erythropoietin

Interventions

erythropoietin DRUG

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.

Also known as: epo

Erythropoietin

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy male and female volunteers.
• Age between 18-40 years.
• Body mass index 17-27.
• Normal haemoglobin levels (Hb males 13.5-18g/dL, females 12-16g/dL).
• Reticulocyte count within reference values (32-110G/L).
• S-Iron within reference values (males 60-150µg/dl, females 40-150µg/dL).
• Serum ferritin within reference values (females 10-140µg/L, males 20-280µg/L).
• CRP within reference values (\<1,0mg/dL).
• Signed informed consent.
• Normal findings in medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant for this study.
• Woman of child bearing potential must agree to practice effective barrier methods for birth control.

You may not qualify if:

• Smoking.
• Regular use of medication and food supplements containing iron.
• Abuse of alcoholic beverages and drugs.
• Participation in a clinical trial in the 3 weeks preceding the study.
• Foreseen inability to attend to scheduled study visits.
• Deficiency in folate (\<3.4nmol/L) or vitamin B12 (\<118pmol/L) (reevaluation after supplementation is allowed).
• Evidence of hypertension, pathologic hyperglycemia, hyperlipidemia. AST and/or ALAT \> 3xULN (AST males \> 105U/L, females \>93U/; ALAT males \> 135U/L, females \>102U/L).
• Symptoms of a clinically relevant illness during 3 weeks prior the first study day.
• History or presence of gastrointestinal, liver or kidney disease, or other conditions known to interfere with distribution, metabolism or excretion of erythropoietin.
• Blood donation during the previous 3 weeks prior to the first study day.
• History of hypersensitivity erythropoietin.
• Pregnancy or lactation period.
• Any medical condition that, in the opinion of the investigator, would interfere with safety of the subject or interference of the objectives of the study.

Sponsors & Collaborators

• Medical University of Vienna: lead

Study Sites (1)

Medical University of Vienna

Vienna, 1090, Austria

Location

Related Publications (1)

• Heinisch BB, Vcelar B, Kapiotis S, Blann A, Wolzt M, Siller-Matula JM, Jilma B. The effect of erythropoietin on platelet and endothelial activation markers: a prospective trial in healthy volunteers. Platelets. 2012;23(5):352-8. doi: 10.3109/09537104.2011.631621. Epub 2011 Nov 18.

  PMID: 22098110 DERIVED

MeSH Terms

Conditions

Thrombosis; Hypertension; Coitus

Interventions

Erythropoietin; Eosinophil Peroxidase

Condition Hierarchy (Ancestors)

Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Sexual Behavior; Behavior

Intervention Hierarchy (Ancestors)

Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors; Peroxidases; Oxidoreductases; Enzymes; Enzymes and Coenzymes; Eosinophil Granule Proteins; Immunoproteins; Blood Proteins

Study Officials

• Michael Wolzt, Prof.

  Medical University of Vienna

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 8, 2011
• First Posted: July 12, 2011
• Study Start: November 1, 2006
• Primary Completion: February 1, 2007
• Study Completion: July 1, 2007
• Last Updated: July 14, 2011

Record last verified: 2011-07

Locations

AU (1)