The immunomodulatory effects of phlebotomy
- Conditions
- blood losshemorraghe1001884910021460
- Registration Number
- NL-OMON41161
- Lead Sponsor
- niversitair Medisch Centrum Sint Radboud
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 10
- Male
- Age >18 and <36 years
- Healthy as concluded from medical history
- 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 100 ml of blood due to any cause, within 3 months preceding phlebotomy (not counting blood withdrawn during screening visit)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 50 ml of blood due to any cause, within 1 month preceding phlebotomy (not counting blood withdrawn during screening visit)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(not counting blood withdrawn during screening visit)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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Change in ex vivo TNF-* production of whole blood, induced by incubation with<br /><br>LPS, on day -1, 0, 1, 3, 5, 7, 14, 21 and 28 following the withdrawal of 500<br /><br>ml of blood at the blood bank. </p><br>
- Secondary Outcome Measures
Name Time Method <p>- the change in ex vivo production of other cytokines (IL-6, IL10) of whole<br /><br>blood elicited by incubation with LPS, on day -1, 0, 1, 3, 5, 7, 14, 21 and 28<br /><br>following the withdrawal of 500 ml of blood at the blood bank.<br /><br>- Changes in hemoglobin, hematocrit, white blood cell count and differential on<br /><br>day -1, 0, 1, 3, 5, 7, 14, 21 and 28 following the withdrawal of 500 ml of<br /><br>blood at the blood bank.<br /><br>- Changes in plasma hepcidin concentration in the 28 days following the<br /><br>withdrawal of 500 ml of blood at the blood bank<br /><br>- Changes in other markers of iron homeostasis (serum iron, transferrin<br /><br>saturation, ferritin) in the 28 days following the withdrawal of 500 ml of<br /><br>blood at the blood bank</p><br>