Retrovirus Epidemiology Donor Study-II (REDS II) Donor Iron Status Evaluation Study (RISE) - Catalog

Name

Retrovirus Epidemiology Donor Study-II (REDS II) Donor Iron Status Evaluation Study (RISE)

Accession Number

HLB00861111a

Acronym

REDS II-RISE

Related studies

BSI Study IDs

RSE

Is public use dataset

False

Keywords

Has Study Datasets

True

Has Specimens

True

Specimen ID Type

Coded

Study Website

The Framingham Heart Study Group requires that the requestor must obtain full or expedited IRB/Ethics Committee review and approval to obtain these data. Waivers or a determination that the research is exempt from ethical regulations do not suffice.

False

Study type

Epidemiology Study

Collection Type

Open BioLINCC Study

Cohort type

Adult

Interventions

Study Open Date (Data)

2011-08-31

Study Open Date (Specimens)

2011-08-31

Date materials available

2010-09-14

Last updated

None

Study period

2007-2009

Study Contacts
NHLBI Division

DBDR

Classification

Transfusion Medicine

HIV study classification

non-HIV

COVID study classification

non-COVID

Pre-Website # of Specimens Shipped

0

# of Returned Specimens

0

Primary Publication URLs
N/A
Conditions

Blood Donors
Blood Transfusion

Objectives

The Retrovirus Epidemiology Donor Study-II (REDS-II) Donor Iron Status Evaluation Study (RISE) was designed to evaluate the effects of blood donation intensity on iron and hemoglobin (Hb) status, assess factors that could modify that relationship, and provide data to help formulate optimal whole blood donation frequency.

Background

Previous studies have shown that regular blood donors are at risk of iron deficiency. Also, a polymorphism in transferrin, which increases the likelihood that menstruating women will be iron deficient, and several genes for hemochromatosis were described in other previous studies. Findings from these studies lead to the possibility that genetic markers might define “at-risk” and “protected” donor groups with respect to iron depletion in blood donors. In addition, none of the previous donor studies had assessed the influence of racial/ethnic or socioeconomic factors, nor behavioral variables and dietary intake. Also, the availability of new tests of body iron status provided further opportunities to detect or prevent this problem. For these reasons, the National Heart, Lung, and Blood Institute’s (NHLBI) Retrovirus Epidemiology Donor Study – II (REDS-II) program conducted the REDS-II Donor Iron Status Evaluation (RISE) whereby blood donors were followed prospectively for 15-24 months to provide an in-depth and contemporary evaluation of iron status in a US blood donor population.

Subjects

The RISE study was a longitudinal multi-center study conducted between 2007 and 2009. All six REDS-II blood centers participated in the study: American Red Cross New England Region, Dedham, MA; the American Red Cross Southern Region, Atlanta, Georgia; the Blood Center of Wisconsin, Milwaukee, Wisconsin; the Hoxworth Blood Center/University of Cincinnati Medical Center, Cincinnati, Ohio; the Institute for Transfusion Medicine, Pittsburgh, Pennsylvania; and the Blood Centers of the Pacific, San Francisco, California. Two cohorts (2,425 whole blood or double red blood cell donors total) were established; one consisted of 888 first-time (FT) or reactivated (RA) donors and the other consisted of 1,537 frequent donors. The FT/ RA cohort consisted of men and women who had either never given blood before (FT) or had not given a donation in the two years before enrollment (RA). The frequent donor cohort consisted of men who had given the equivalent of ≥ 3 and women who had given ≥ 2 red blood cell units in the last year (or equivalent double-red blood cell donations). Male and females donors were recruited equally for each cohort. Most sites where donors were recruited were fixed rather than mobile sites. Only individuals who successfully donated whole blood or double-RBC units, were not deferred at their enrollment visit, and had agreed to donate frequently in the following 24 months were included in the study.

Design

Data on previous blood donation history; smoking history; diet; use of vitamins, supplements, and aspirin; and reproductive history (female donors) were collected through a self-administered enrollment questionnaire. Also, blood donation activity before and after enrollment, height, weight, country of birth, race and/or ethnicity, and highest educational level were compiled from blood center records and the donor information form that donors completed at the time of donation at the REDS-II centers. At enrollment, ferritin, soluble transferrin receptor (sTfR), and fingerstick and venous hemoglobin were determined. Models to predict two measures of iron deficiency, absent iron stores (AIS) and iron-deficient erythropoiesis (IDE), and hemoglobin deferral were developed. Absent iron stores (AIS) were indicated by a ferritin level of less than 12 ng/mL and iron-deficient erythropoiesis (IDE) by a log(sTfR/ferritin) value of 2.07 or greater, corresponding to the 97.5 percentile of the distribution of the log (sTfR/ferritin) in FT/RA males at enrollment. For hemoglobin deferral, a donor was deferred by current standards if their hemoglobin was < 12.5 g/dL or hematocrit < 38% using routine fingerstick methods, which differed among the six centers.

Conclusions

A large proportion of both female and male frequent blood donors have iron depletion. Strong associations between higher prior donation intensity and a shorter time since last donation and iron depletion were observed. Iron depletion also developed in a high proportion of returning FT/RA donors (51% of females and 20% of male had IDE on follow up). Other than donation intensity and time since last donation, gender, weight, age, and the use of self-administered iron supplements were found to be important independent predictors of AIS and/or IDE. Time since last red cell donation was a highly significant factor for hemoglobin deferral as were black race, female gender and younger age in women. Reducing the frequency of blood donation is likely to reduce the prevalence of iron deficiency among blood donors, as might implementing routine iron supplementation.

Disease classification

Publications

Brittenham, G. M. (2011), Iron deficiency in whole blood donors. Transfusion, 51: 458–461.

Cable, R. G., Glynn, S. A., Kiss, J. E., Mast, A. E., Steele, W. R., Murphy, E. L., Wright, D. J., Sacher, R. A., Gottschall, J. L., Vij, V., Simon, T. L. and for the NHLBI Retrovirus Epidemiology Donor Study-II (REDS-II) (2011), Iron deficiency in blood donors: analysis of enrollment data from the REDS-II Donor Iron Status Evaluation (RISE) study. Transfusion, 51: 511–522.


Cable, R. G., Glynn, S. A., Kiss, J. E., Mast, A. E., Steele, W. R., Murphy, E. L., Wright, D. J., Sacher, R. A., Gottschall, J. L., Tobler L.H., Simon, T. L. and for the NHLBI Retrovirus Epidemiology Donor Study-II (REDS-II) (2011), Iron deficiency in blood donors: the REDS-II Donor Iron Status Evaluation (RISE) study. Transfusion, In Press.


Cable RG, Steele WR, Melmed RS, Johnson B, Mast AE, Carey PM, Kiss JE, Kleinman SH, Wright DJ for the NHLBI Retrovirus Epidemiology Donor Study-II (REDS-II). The Difference Between Fingerstick And Venous Hemoglobin/Hematocrit Varies by Gender and Iron Stores. Transfusion, In Press.

Mat types

DNA
Packed Red Blood Cells Partially Suspended
Plasma

The study population available in BioLINCC study data may be lower than total study enrollment due to Informed Consent restrictions and other factors.

  • Subjects

    First time/Reativated donor: 888

    Repeat donor: 1537


    Last Modified: July 28, 2014, 3 p.m.
  • Age

     

    First time/Reactivated donor

    Repeat donor

    All

    N

    %

    N

    %

    N

    %

    16-20

    150

    16.89

    44

    2.86

    194

    8.00

    21-25

    93

    10.47

    63

    4.10

    156

    6.43

    26-30

    99

    11.15

    66

    4.29

    165

    6.80

    31-35

    62

    6.98

    68

    4.42

    130

    5.36

    36-40

    97

    10.92

    114

    7.42

    211

    8.70

    41-45

    82

    9.23

    143

    9.30

    225

    9.28

    46-50

    69

    7.77

    220

    14.31

    289

    11.92

    51-55

    86

    9.68

    229

    14.90

    315

    12.99

    56-60

    70

    7.88

    234

    15.22

    304

    12.54

    61-65

    38

    4.28

    171

    11.13

    209

    8.62

    66-70

    21

    2.36

    108

    7.03

    129

    5.32

    71-75

    15

    1.69

    51

    3.32

    66

    2.72

    76-80

    6

    0.68

    18

    1.17

    24

    0.99

    81-85

    .

    .

    7

    0.46

    7

    0.29

    86-87

    .

    .

    1

    0.07

    1

    0.04

     

    Last Modified: Aug. 25, 2015, 4:58 p.m.
  • Sex
     

     

    First time/Reactivated donor

    Repeat donor

    All

    N

    %

    N

    %

    N

    %

    Female

    481

    54.17

    769

    50.03

    1250

    51.55

    Male

    407

    45.83

    768

    49.97

    1175

    48.45

     

    Last Modified: Aug. 25, 2015, 4:58 p.m.
  • Race

     

    First time/Reactivated donor

    Repeat donor

    All

    N

    %

    N

    %

    N

    %

    Missing

    14

    1.58

    3

    0.20

    17

    0.70

    Asian

    45

    5.07

    31

    2.02

    76

    3.13

    Black

    53

    5.97

    63

    4.10

    116

    4.78

    Hispanic

    40

    4.50

    36

    2.34

    76

    3.13

    Other

    16

    1.80

    13

    0.85

    29

    1.20

    White

    720

    81.08

    1391

    90.50

    2111

    87.05

     

    Last Modified: Aug. 25, 2015, 4:58 p.m.

Please note that biospecimen availability is subject to review by the NHLBI, BioLINCC, and the NHLBI Biorepository. Certain biospecimens may not be made available for your request. Section 3 of the BioLINCC handbook describes the components of the review process

  • Material Types

    Last Modified: Nov. 30, 2015, 3:47 p.m.
  • General Freeze/Thaw Status

    Type here...


    Last Modified: July 28, 2014, 8:51 a.m.
  • Visits (Vials)

    5/31/2018

      Plasma DNA PRBC-BC Total
    Baseline 6,154 622 4,675 11,451
    Interim 2 3,338 0 0 3,338
    Interim 3 2,823 0 0 2,823
    Interim 4 2,280 0 0 2,280
    Interim 5 1,803 0 0 1,803
    Interim 6 1,295 0 0 1,295
    Interim 7 914 0 0 914
    Interim 8 542 0 0 542
    Interim 9 298 0 0 298
    Interim 10 128 0 0 128
    Interim 11 47 0 0 47
    Interim 12 20 0 0 20
    Interim 13 3 0 0 3
    Interim 14 8 0 0 8
    Interim 18 2 0 0 2
    Interim 21 2 0 0 2
    Final 2,742 0 0 2,742

     

    Last Modified: May 31, 2018, 5:04 p.m.
  • Visits (Subjects)

    5/31/2018

      Plasma
    Total number of subjects Average volume (ml) per subject
    Baseline 2,344 2.27
    Interim 2 1,643 2.22
    Interim 3 1,358 2.20
    Interim 4 1,108 2.16
    Interim 5 875 2.17
    Interim 6 624 2.15
    Interim 7 432 2.25
    Interim 8 256 2.30
    Interim 9 138 2.28
    Interim 10 58 2.18
    Interim 11 20 2.34
    Interim 12 11 2.08
    Interim 13 2 1.70
    Interim 14 4 2.50
    Interim 18 1 2.70
    Interim 21 1 2.75
    Final 1,278 2.17
     
      PRBC-BC
    Total number of subjects Average vials per subject
    Baseline 2,344 1.99

     

      DNA
    Total number of subjects Average mass (µg) per subject Average vials per subject
    Baseline 129 23.95 4.82

     

    Last Modified: May 31, 2018, 5:04 p.m.