ThrombosisPhase 4NCT01392612
Erythropoietin and Platelet Activation Markers
A Phase 4 study testing erythropoietin in people with Thrombosis and Hypertension, run by Medical University of Vienna at 1 site in Austria.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Thrombosis, Hypertension
- What is being tested?
- erythropoietin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteAustria
- Study dates
- Nov 2006to Jul 2007
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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).
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- 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.
Who cannot join
- 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).
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Erythropoietin on Platelet Activation Markers: a Prospective Study in Healthy Volunteers
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.
Read the detailed description
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.
- Conditions
- Thrombosis, Hypertension
- Being tested
- erythropoietin
- Keywords
- thrombosis, hypertension, gender, endothelium
- Medical subject headings
- Thrombosis, Hypertension, Coitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
erythropoietinDrug
Also called epo
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.
| Study group | Role | What they receive |
|---|---|---|
| Erythropoietin | Other | all subjects received epo iv. Receives: Drug: erythropoietin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: platelet activation markers were measured 4, 24, 48 and 72 hours after administration of iv EPO
Secondary outcomes (1)
change in erythropoietin levels
We wanted to examine erythropoietin-levels after administration of EPO at mentioned time points.
Measured: erythropoietin levels were measured 4, 24, 48 and 72 hours after administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2011 (estimated)
- Study startNov 2006
- Primary completionFeb 2007
- Study completionJul 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ThrombosisStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Investigators
- Michael Wolzt, Prof., Principal investigator, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01392612
- Sponsor's protocol ID
- EPO1
- Status last verified
- Jul 2011
- First submitted
- 8 Jul 2011
- Last updated
- 14 Jul 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 22098110
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Erythropoietin on Platelet Activation Markers: a Prospective Study in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT01392612
- Acronym / sponsor ID
- EPO1
- Conditions
- Thrombosis, Hypertension
- Keywords
- thrombosis, hypertension, gender, endothelium
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- Nov 2006
- Primary completion
- Feb 2007 (actual)
- Study completion
- Jul 2007 (actual)
- First posted
- 12 Jul 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Erythropoietin | Other | Drug: erythropoietinall subjects received epo iv. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- 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).
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| erythropoietinAlso: epoSubjects 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. | Drug | Erythropoietin |
Primary outcome
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.
1 secondary outcome
change in erythropoietin levels
Time frame: erythropoietin levels were measured 4, 24, 48 and 72 hours after administration
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2011.
- Derived from this study: PubMed 22098110Heinisch 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Wolzt, Prof. principal investigator
Medical University of Vienna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing erythropoietin in people with Thrombosis and Hypertension, run by Medical University of Vienna at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in platelet activation markers (time frame: platelet activation markers were measured 4, 24, 48 and 72 hours after administration of iv EPO). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01392612, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2011.