NCT02031614

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2014

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

January 8, 2014

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 9, 2014

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2014

Completed
Last Updated

January 9, 2014

Status Verified

January 1, 2014

Enrollment Period

4 months

First QC Date

January 8, 2014

Last Update Submit

January 8, 2014

Conditions

Anemia

Keywords

anemiablood withdrawalphlebotomyinnate immunityImmune reponse

Outcome Measures

Primary Outcomes (1)

  • ex vivo TNF-afpha production of whole blood in reponse to incubation with E. Coli LPS

    Blood will be drawn on day -1, 0, 1, 3, 5, 7, 14, 21 and 28 after phlebotomy, to assess ex vivo cytokine production.

    1 day before till 28 days after phlebotomy

Secondary Outcomes (6)

  • ex vivo IL6 and IL-10 production of whole blood in response to incubation with E.Coli LPS

    1 day before till 28 days after phlebotomy

  • Changes in hemoglobin, hematocrit, white blood cell count and differential

    1 day before till 28 after phlebotomy

  • Changes in hemoglobin, hematocrit, white blood cell count and differential

    1 day before till 28 after phlebotomy

  • Changes in plasma hepcidin

    1 day before till 28 after phlebotomy

  • Changes in other markers of iron homeostasis (serum iron, transferrin saturation, ferritin)

    1 day before till 28 after phlebotomy

  • +1 more secondary outcomes

Study Arms (1)

Phlebotomy

EXPERIMENTAL

Subjects in this arm will undergo phlebotomy of 500 mL of blood.

Procedure: Phlebotomy

Interventions

PhlebotomyPROCEDURE

Withdrawal of 500 mL of whole blood.

Phlebotomy

Eligibility Criteria

Age18 Years - 35 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Radboudumc

Nijmegen, Gelderland, 6500 HB, Netherlands

Location

MeSH Terms

Conditions

Anemia

Interventions

Phlebotomy

Condition Hierarchy (Ancestors)

Hematologic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Blood Specimen CollectionSpecimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesTherapeuticsSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • P Pickkers, MD, PhD

    Radboud University Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

L T van Eijk, MD, MSc

CONTACT

+31 24 3653879L.vanEijk@Radboudumc.nl

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 8, 2014

First Posted

January 9, 2014

Study Start

January 1, 2014

Primary Completion

May 1, 2014

Study Completion

May 1, 2014

Last Updated

January 9, 2014

Record last verified: 2014-01

Locations

NL(1)