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  • Infanti L
  • Leitner G
  • Moe M
  • Pehlic V
  • Cattaneo M
  • et al.
Front Med (Lausanne). 2024 Mar 19;11:1362941 doi: 10.3389/fmed.2024.1362941.
POPULATION:

Healthy persons with elevated ferritin and HFE variants (n= 30).

INTERVENTION:

Phlebotomy (removal of 450 mL whole blood) (n= 16).

COMPARISON:

Erythrapheresis (removal of 360 mL red blood cells) (n= 14).

OUTCOME:

The primary endpoint was the number of procedures needed to the ferritin target. The secondary objectives were duration of treatment and compliance. Twenty-seven participants completed the study. Treatment arm and HFE variant influenced the primary endpoint significantly. To ferritin levels <100 ng/mL, a median number of 7.5 (IQR= 6.2, 9.8) phlebotomies and 4.0 (IQR= 3.0, 5.8) erythraphereses was needed during a median of 66.5 days (IQR= 49, 103) and 78.5 days (IQR= 46, 139), respectively. Low haemoglobin (Hb) was the principal reason for protocol violation; anaemia occurred in 13 participants (48%). Immediate complications were infrequent; fatigue was reported after 25% of phlebotomies and 45% of erythraphereses. Thirty-five procedures were postponed because of low Hb and 15 for non-medical reasons. The median interval was 7.0 (IQR= 7.7) and 14.0 (IQR= 14, 20) days between phlebotomies and erythraphereses, respectively.

BACKGROUND:

Elevated serum ferritin with/without HFE variants in asymptomatic persons leads frequently to referral for blood donation. Hemochromatosis (p.C282Y/p.C282Y) only requires treatment. We evaluated safety and feasibility of iron removal in healthy persons with elevated ferritin and HFE variants using blood donation procedures.

MATERIALS AND METHODS:

Thirty subjects with ferritin >200 ng/mL (women) or >300 ng/mL (men) with p.C282Y/p.C282Y, p.C282Y/p.H63D or p.H63D/p.H63D were randomized to weekly phlebotomy (removal of 450 mL whole blood) or erythrapheresis (removal of 360 mL red blood cells) every 14 days. The ferritin target was <100 ng/mL. A full blood count and ferritin were measured at each visit. Hemoglobin (Hb) ≥140 g/L was required at inclusion. If Hb dropped to <120 g/L (women) or <130 g/L (men), procedures were postponed (7 or 14 days). Primary endpoint was the number of procedures needed to the ferritin target; secondary objectives were duration of treatment and compliance. The treatment effect was tested with Poisson regression; number of procedures and treatment duration were compared between study arms with the Kruskal-Wallis test.

RESULTS:

Twenty-five of 30 participants were men (83%); mean age was 47 years (SD 10.5), mean BMI 26.6 kg/m2 (SD 3.6); 17 had p.C282Y/p.C282Y, nine p.C282Y/p.H63D, four p.H63D/p.H63D. Median baseline Hb was 150 g/L (IQR 144, 1,559), median ferritin 504 ng/mL (IQR 406,620). Twenty-seven subjects completed the study. Treatment arm (p < 0.001) and HFE variant (p = 0.007) influenced the primary endpoint significantly. To ferritin levels <100 ng/mL, a median number of 7.5 (IQR 6.2, 9.8) phlebotomies and 4.0 (IQR 3.0, 5.8) erythraphereses (p = 0.001) was needed during a median of 66.5 days (IQR 49,103) and 78.5 days (IQR 46139), respectively (p = 0.448). Low Hb was the principal reason for protocol violation; anemia occurred in 13 participants (48%). Immediate complications were infrequent; fatigue was reported after 25% of phlebotomies and 45% of erythraphereses. Thirty-five procedures were postponed because of low Hb and 15 for non-medical reasons. The median interval was 7.0 (IQR 7.7) and 14.0 (IQR 14, 20) days between phlebotomies and erythraphereses, respectively.

CONCLUSION:

Blood donation procedures remove iron effectively in HC, but frequent treatments cause Hb decrease and fatigue that can impair feasibility.