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The immunomodulatory effects of phlebotomy

The immunomodulatory effects of phlebotomy - The immunomodulatory effects of phlebotomy

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON41161
Enrollment
10
Registered
2014-03-17
Start date
2014-03-17
Completion date
Unknown
Last updated
2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

blood loss hemorraghe

Interventions

Phlebotomy (withdrawal of 500 mL volbloed)

Sponsors

Universitair Medisch Centrum Sint Radboud
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Male - Age >18 and

Exclusion criteria

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 100 ml of blood due to any cause, within 3 months preceding phlebotomy (not counting blood withdrawn during screening visit) - Having lost 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 50 ml of blood due to any cause, within 1 month preceding phlebotomy (not counting blood withdrawn during screening visit) - Having lost 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20 ml blood due to any cause, within 1 week preceding phlebotomy (not counting blood withdrawn during screening visit) - Family history of thallasemia, sickle cell disease, hereditary hemochromatosis, or iron refractory iron deficiency anemia - Signs of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

Design outcomes

Primary

MeasureTime frame
Change in ex vivo TNF-* production of whole blood, induced by incubation with LPS, on day -1, 0, 1, 3, 5, 7, 14, 21 and 28 following the withdrawal of 500 ml of blood at the blood bank.

Secondary

MeasureTime frame
- the change in ex vivo production of other cytokines (IL-6, IL10) of whole blood elicited by incubation with LPS, on day -1, 0, 1, 3, 5, 7, 14, 21 and 28 following the withdrawal of 500 ml of blood at the blood bank. - Changes in hemoglobin, hematocrit, white blood cell count and differential on day -1, 0, 1, 3, 5, 7, 14, 21 and 28 following the withdrawal of 500 ml of blood at the blood bank. - Changes in plasma hepcidin concentration in the 28 days following the withdrawal of 500 ml of blood at the blood bank - Changes in other markers of iron homeostasis (serum iron, transferrin saturation, ferritin) in the 28 days following the withdrawal of 500 ml of blood at the blood bank

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)