Intravenous High Dose Iron in Blood Donors
Condition: Iron Deficiency
MeSH terms: Anemia, Iron-Deficiency; Iron Deficiencies
Study type: Interventional
Phase: Phase 3

Summary: 
      2-3% of the population participates in blood donation programmes. Traditionally, safety
      issues in transfusion medicine have been concentrating on product and recipient safety.
      Extensive efforts including strict donor inclusion criteria and testing for important
      transmissible infections have substantially improved product quality. One of the most common
      risks of blood donation is iatrogenic iron deficiency. It may affect up to 30% of regular
      blood donors because each whole blood donation causes a loss of 200 to 250 mg of iron.
      Although this has been known for at least 50 years, iron deficiency is not routinely assessed
      or treated in this population. Contributing factors include donation frequency, lower weight
      and female gender. Women have lower iron reserves and in premenopausal women, the daily
      required amount of iron is higher than in men. Besides anemia, iron deficiency may lead to
      fatigue and impaired cognitive and physical performance. Oral iron substitution is often
      associated with significant gastrointestinal side effects leading to poor compliance. Today,
      intravenous (iv.) iron preparations are well tolerated and allow the application of a large
      dose of 1000mg in one visit. Our hypothesis is that in blood donors with iron deficiency
      intravenous iron is feasible and preferable to oral iron because of its high efficacy and
      optimal compliance with a similar safety profile that has been extensively studied in other
      populations than blood donors.
    

Detailed description: 
      Iron deficiency is possibly the most prevalent worldwide nutritive deficiency and it has been
      estimated that > 500 million people have adverse effects as a result. Total body iron amounts
      to 3 to 4.5 grams, the largest part being bound to hemoglobin in red cells.

      One of the most common risks of blood donation is iatrogenic iron deficiency which may affect
      up to 30% of regular blood donors. Each whole blood donation means a whole blood loss of 450
      ml ±10% for the bag and additional samples for the required tests, corresponding to a loss of
      200 to 300 mg of iron. It has been estimated that 10 apheresis donations equal 1 whole blood
      donation. Contributing factors include donation frequency, low body weight and female gender.
      In Austria, the maximal annual donation frequency is 50x for plasmapheresis, 26x for
      plateletpheresis and 4 (women) respectively 6x (men) for whole blood donations. Although the
      frequent donation-induced development of iron depletion has been recognized for at least 50
      years, iron deficiency is not routinely assessed or treated in this population. Recently it
      was reported that the presence of pica, the bizarre consumption of nonnutritive substances
      such as ice cubes, is associated with a high probability of iron depletion in blood donors.

      Contributing factors to a poor iron status in blood donors include donation frequency, lower
      weight and female gender. Women also have lower iron reserves and in premenopausal women, the
      daily required amount of iron is higher than in men. Besides anemia, iron deficiency may lead
      to fatigue and impaired cognitive and physical performance. Several trials have evaluated
      different regimens of iron substitution in blood donors and demonstrated good treatment
      compliance and efficacy in improving iron status. Oral iron substitution is often associated
      with significant gastrointestinal side effects leading to poor compliance. Today, high-dose
      intravenous (iv.) iron preparations are available, well tolerated and allow for the
      application of a large dose of 1000mg in one visit.
    

Intervention name(s): ferric carboxymaltose; oral iron
Intervention type(s): Drug; Drug
Intervention description(s): 1 g intravenously per infusion; oral tablets of 100mg iron over 8 weeks, total dose 10g
Other intervention name(s): ferinject; Ferretab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: iron depletion; donor safety; blood donation; transfusion medicine; iron deficiency; intravenous iron; fatigue; restless legs syndrome; anemia