iron status in blood donors barbara j. bryant, md university of texas medical branch galveston,...
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Iron Status in Blood Iron Status in Blood DonorsDonors
Barbara J. Bryant, MDBarbara J. Bryant, MD
University of Texas Medical BranchUniversity of Texas Medical Branch
Galveston, Texas Galveston, Texas
andand
Department of Transfusion MedicineDepartment of Transfusion Medicine
National Institutes of HealthNational Institutes of Health
Bethesda, MarylandBethesda, Maryland
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Iron Deficiency in Blood Donors
Iron deficiency in 1st time and repeat blood donors is a challenge in transfusion medicine
Iron is an essential element lost with each blood donation 242 17 mg for men 217 11 mg for women
Normal iron stores 1000 mg men 350 mg women
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Iron Deficiency in Blood Donors In order for a donor to
compensate for iron lost in donating blood: Iron is mobilized from the body’s
iron stores Increased iron absorption from diet
Balance can be difficult to maintain in premenopausal females and regular blood donors since there is ongoing loss
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Role of Oral Iron Replacement in the Routine Management of
Blood Donors (I.R.O.N. Protocol: “Iron Replacement or
Not”) NIH Protocol 06-CC-0166
Background 8-12% of all WB donor visits to DTM
end in deferral for low FS Hgb 3 - 4 year study at the NIH
Up to 2000 low hemoglobin donors Screening capillary fingerstick sample
by HemaCue device Up to 500 control donors
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Goals of Study
Analyze the cause of low FS Hgb Quantitate the prevalence of Fe def Study the long-term effects of blood
donation on donors’ hemoglobin levels and iron stores
Evaluate the safety, practicality, and efficacy of distributing oral replacement iron to blood donors
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Laboratory Testing
CBC Iron studies
Ferritin % transferrin saturation Serum iron Transferrin
Other labs (as indicated) Hemoglobin electrophoresis, etc.
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Donor Health History Screening Questionnaire Focused medical history
screening to identify causes of low hemoglobin values and depleted or deficient iron stores
Identify concerns requiring referral to PCP
Identify need for additional laboratory testing
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Iron Stores Definitions
Women: Ferritin normal range = 9-120 mcg/L Fe deficient: ferritin < 9 mcg/L Fe depleted: ferritin = 9-19 mcg/L Fe replete: ferritin ≥ 20 mcg/L
Men: Ferritin normal range = 18-370 mcg/L Fe deficient: ferritin < 18 mcg/L Fe depleted: ferritin = 18-29 mcg/L Fe replete: ferritin ≥ 30 mcg/L
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Role of Oral Iron Replacement in the Role of Oral Iron Replacement in the Routine Management of Blood DonorsRoutine Management of Blood Donors
(I.R.O.N. Protocol: “Iron Replacement or Not”) (I.R.O.N. Protocol: “Iron Replacement or Not”) NIH Protocol 06-CC-0166NIH Protocol 06-CC-0166
39-month period 39-month period 1355 “Low FS Hemoglobin” donors 1355 “Low FS Hemoglobin” donors
1180 (87%) females, mean FS Hgb 11.81180 (87%) females, mean FS Hgb 11.8 175 (13%) males, mean FS Hgb 11.9175 (13%) males, mean FS Hgb 11.9
410 “Control” donors410 “Control” donors 147 (36%) females, mean FS Hgb 13.7147 (36%) females, mean FS Hgb 13.7 263(64%) males, mean FS Hgb 14.9263(64%) males, mean FS Hgb 14.9
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Low Hgb Group (n= 1355)
Control Group (n = 410) p value
FemalesNumber of donors 1180 (87%) 147 (36%) <0.0001
Age (range) 40 (17-82) 46 (23-69) <0.0001
MalesNumber of donors 175 (13%) 263 (64%) <0.0001
Age (range) 53 (22-85) 48 (18-80) 0.0005
Race
Caucasian 924 (68%) 339 (83%) <0.0001
African American 230 (17%) 21 (5%) <0.0001
Asian 81(6%) 33 (8%) 0.1370
Hispanic 52 (4%) 7 (2%) 0.0403
Other 68 (5%) 10 (2%) 0.0275
First Time Donors
Number of donors 383 (28%) 46 (11%) <0.0001
# Prior Donations
Females WB (range) 10.2 (1-103) 15.8 (1-103) 0.0065
Males WB (range) 26.7 (1-172) 25.4 (1-185) 0.7185
Hgb = hemoglobin. WB = whole blood.
Donor Demographics
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ResultsResults
Low Hgb GroupLow Hgb Group Females:Females:
3030% iron depleted% iron depleted 2323% iron deficient% iron deficient
Males:Males: 88% iron depleted% iron depleted 5353% iron deficient% iron deficient
Control GroupControl Group Females:Females:
2929% iron depleted% iron depleted 1010% iron deficient% iron deficient
Males:Males: 1818% iron depleted% iron depleted 2121% iron deficient% iron deficient
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Association of FS Hgb Levels Association of FS Hgb Levels with Iron with Iron Status and Venous and Venous
Hgb in Hgb in ♀♀
WOMEN (n=1218)
Fingerstick Hemoglobin Levels (g/dL)
< 11.5 11.5-11.9 12.0-12.4 > 12.5
Iron Status % (n) %Menopause (n=256) (n=303) (n=516) (n=143)
Fe deficient40% (102)
4%24% (73)
4%14% (70)
1%10% (14)
3%
Fe depleted26% (66)
5%28% (86)
4%32% (166)
5%29% (42)
7%
Fe replete34% (88)
6%48% (144)
11%54% (280)
13%61% (87)
24%
Venous Hgb > 12.5 18% (47) 35% (106) 55% (283)80% (115)
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Association of FS Hgb Levels Association of FS Hgb Levels with Iron with Iron Status and Venous and Venous
Hgb in Hgb in ♂♂
MEN(n=420)
Fingerstick Hemoglobin Levels (g/dL)
< 12.012.0-12.4
12.5-12.9
13.0-13.4 > 13.5
Iron Status % (n)
(n=74) (n=89) (n=9) (n=19) (n=229)
Fe deficient 62% (46) 46% (41) 56% (5) 26% (5) 19% (44)
Fe depleted 5% (4) 10% (9) 22% (2) 26% (5) 18% (40)
Fe replete 33% (24) 44% (39) 22% (2) 48% (9) 63% (145)Venous Hgb
> 12.5 55% (41) 69% (61) 78% (7) 95% (18) 100%(229)
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FeSO4 or FeGluc 325 mg #60 1 tablet daily x 60 days
68% compliance 1065/1342 (79%) given FeSO4
235/1065 (22%) developed 235/1065 (22%) developed intolerance and switched to intolerance and switched to FeGluconateFeGluconate
46/1065 (4%) intolerant to both 46/1065 (4%) intolerant to both FeSO4 and FeGluconateFeSO4 and FeGluconate
Compliance with Oral Iron Compliance with Oral Iron Therapy and Adverse EffectsTherapy and Adverse Effects
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Compliance Compliance withwith Oral Iron Oral Iron Therapy and Adverse EffectsTherapy and Adverse Effects
277/1342 (21%) reported intolerance to FeSO4 and started on FeGluconate 23/277 (8%) intolerant to FeGluconate
Overall, only 69/1342 (5%) intolerant to both FeSO4 and FeGluconate
Most common complaint – GI discomfort
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Effect of Iron Therapy in Low-Fingerstick Hgb Donors
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Effect of Iron Therapy in Low-Fingerstick Hgb Donors
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Effect of Iron Therapy in Low Fingerstick Hgb Donors without Iron Depletion/Deficiency
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Effect of Iron Therapy in Low Fingerstick Hgb Donors without Iron Depletion/Deficiency
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Ferritin Values on Initial and Subsequent Visits of Donors
in Control Group
A. Control Donors not on Iron Therapy
B. Control Donors Started on Iron therapy after 1st Visit
C. Control Donors Started on Iron Therapy after 2nd Visit
D. Control Donors Started on Iron Therapy after 3rd Visit
E. Control Donors Started on Iron Therapy after 4th Visit
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Safety
No donors were found to have ferritin and transferrin saturation levels suggestive of hemochromatosis
No malignancies reported or detected
All donors with Fe deficiency anemia given letter and copy of lab results to take to PCP
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Correlation of Low MCV, Hemoglobin Levels, and Iron Stores
Apheresis donors at our facility are routinely evaluated with a CBC prior to each donation
Recurrent low red cell mean corpuscular volume (MCV) values (< 80 fL) in the presence of an acceptable hemoglobin ( 12.5 g/dL) in a donor population could be due to: Iron deficiency Hemoglobinopathy, such as alpha or beta
chain variant trait
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Results
In a 15-month period, 30 of 1333 apheresis donors (43% African American, 7% Asian) had repeatedly low MCV values (Table 1)
Iron deficiency was present in 60%: 40% had isolated iron deficiency 20% had iron deficiency plus
hemoglobinopathy
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Results (cont’d)
Hemoglobinopathy without concomitant iron deficiency was found in the remaining 40%
Frequent coexistence of iron deficiency and hemoglobinopathy resulted in a need for further laboratory evaluation, both before and after iron repletion, to confirm the diagnosis
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Table 1. Low MCV Values in Apheresis Blood Donors
Causes Number (n=30)
Percentage
Iron deficiency 12 40
Hemoglobinopathy 12 40
---Alpha thal trait 8
---Hgb S trait and alpha thal trait 2
---Hgb G trait and alpha thal trait 1
---Hgb Lepore trait 1
Iron Deficiency and Hemoglobinopathy 6 20
---Alpha thal trait and iron deficiency 5
---Hgb C trait and iron deficiency 1
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Conclusions - Low MCV Study
The MCV is a useful screening tool to detect iron deficiency and hemoglobinopathy in a healthy blood donor population
Low MCV values should be further investigated in the donor setting to determine if iron replacement therapy is indicated
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Recommendations to FDA
Female donors Lower FS Hgb threshold to 12.0 g/dL
Male donors Raise FS Hgb threshold to 13.0 g/dL
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Diplomatic Recommendations
Administer a 2-month supply of oral iron tablets to all donors with Hgb < 12.5 g/dL Males with previous blood donations:
Refer to PCP if hgb does not respond in 60 days
Males - 1st time donors: Refer to PCP
Males with Hgb < 12g/dL and Females with Hgb < 10g/dL
Refer to PCP
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Evidenced-Based Recommendations
Routinely administer a 2-month supply of oral iron tablets, sufficient to replace iron lost in 1 unit of whole blood, to all whole blood donors Verify non-HH status by single ferritin
level
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Acknowledgements
Sarah J. Arceo, RN Yu Ying Yau, RN Julie A. Hopkins, RN Susan F. Leitman, MD
Harvey G. Klein, MD
NIH Blood Donors