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The Immunomodulatory Effects of Phlebotomy

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ClinicalTrials.gov Identifier: NCT02031614
Recruitment Status : Unknown
Verified January 2014 by Radboud University.
Recruitment status was:  Not yet recruiting
First Posted : January 9, 2014
Last Update Posted : January 9, 2014
Sponsor:
Information provided by (Responsible Party):
Radboud University

Brief Summary:
Although phlebotomy is routinely performed in blood donors, and seemingly does not have significant health risks, it is highly relevant to know what the effect of phlebotomy is on immunity. Alterations in immunity due to phlebotomy could have beneficial effects, like the suppression of the low grade inflammatory process that contributes to atherosclerosis, but in theory could also contribute to a suppressed innate immune response that could increase the risk of infection. This is not only relevant for blood donors, but also for patients suffering from blood loss and for daily clinical practice in which blood is routinely drawn of patients for laboratory determinations.

Condition or disease Intervention/treatment Phase
Anemia Procedure: Phlebotomy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: The Immunomodulatory Effects of Phlebotomy
Study Start Date : January 2014
Estimated Primary Completion Date : May 2014
Estimated Study Completion Date : May 2014

Arm Intervention/treatment
Experimental: Phlebotomy
Subjects in this arm will undergo phlebotomy of 500 mL of blood.
Procedure: Phlebotomy
Withdrawal of 500 mL of whole blood.




Primary Outcome Measures :
  1. ex vivo TNF-afpha production of whole blood in reponse to incubation with E. Coli LPS [ Time Frame: 1 day before till 28 days after phlebotomy ]
    Blood will be drawn on day -1, 0, 1, 3, 5, 7, 14, 21 and 28 after phlebotomy, to assess ex vivo cytokine production.


Secondary Outcome Measures :
  1. ex vivo IL6 and IL-10 production of whole blood in response to incubation with E.Coli LPS [ Time Frame: 1 day before till 28 days after phlebotomy ]
    Blood will be drawn on day -1, 0, 1, 3, 5, 7, 14, 21 and 28 after phlebotomy, to assess ex vivo cytokine production.

  2. Changes in hemoglobin, hematocrit, white blood cell count and differential [ Time Frame: 1 day before till 28 after phlebotomy ]
    Hemoglobin, hematocrit, white blood cell count and differential will be determined on day -1, 0, 1, 3, 5, 7, 14, 21 and 28 following the withdrawal of 500 ml of blood at the blood bank

  3. Changes in hemoglobin, hematocrit, white blood cell count and differential [ Time Frame: 1 day before till 28 after phlebotomy ]
    Hemoglobin, hematocrit, white blood cell count and differential will be determined on day -1, 0, 1, 3, 5, 7, 14, 21 and 28 following phlebotomy

  4. Changes in plasma hepcidin [ Time Frame: 1 day before till 28 after phlebotomy ]
    Plasma hepcidin concentration will be determined at various time points during the 28 days of follow-up, following phlebotomy

  5. Changes in other markers of iron homeostasis (serum iron, transferrin saturation, ferritin) [ Time Frame: 1 day before till 28 after phlebotomy ]
    Changes in parameters of iron homeostasis will be determined at various time points during the 28 days of follow-up, following phlebotomy

  6. Adverse Events [ Time Frame: 1 day before till 28 after phlebotomy ]
    Adverse Events will be assessed with every visit



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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Male
  • Age >18 and <36 years
  • Healthy as concluded from medical history

Exclusion Criteria:

  • Having donated blood to the blood bank within one year preceding phlebotomy
  • Significant blood loss from trauma within one year preceding phlebotomy
  • Having lost > 100 ml of blood due to any cause, within 3 months preceding phlebotomy (not counting blood withdrawn during screening visit)
  • Having lost > 50 ml of blood due to any cause, within 1 month preceding phlebotomy (not counting blood withdrawn during screening visit)
  • Having lost >20 ml blood due to any cause, within 1 week preceding phlebotomy (not counting blood withdrawn during screening visit)
  • Family history of thallasemia, sickle cell disease, hereditary hemochromatosis, or iron refractory iron deficiency anemia
  • Signs of history of infection within 2 weeks preceding phlebotomy
  • History of frequent vasovagal response

Information from the National Library of Medicine

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): NCT02031614


Contacts
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Contact: L T van Eijk, MD, MSc +31 24 3653879 L.vanEijk@Radboudumc.nl

Locations
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Netherlands
Radboudumc
Nijmegen, Gelderland, Netherlands, 6500 HB
Contact: L T van Eijk, MD, MSc    +31 24 3617273      
Principal Investigator: P Pickkers, MD, PhD         
Sub-Investigator: L T van Eijk, MD, MSc         
Sponsors and Collaborators
Radboud University
Investigators
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Principal Investigator: P Pickkers, MD, PhD Radboud University
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Responsible Party: Radboud University
ClinicalTrials.gov Identifier: NCT02031614    
Other Study ID Numbers: Phlebotomy-2014
First Posted: January 9, 2014    Key Record Dates
Last Update Posted: January 9, 2014
Last Verified: January 2014
Keywords provided by Radboud University:
anemia
blood withdrawal
phlebotomy
innate immunity
Immune reponse
Additional relevant MeSH terms:
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Anemia
Hematologic Diseases