Proposed changes to hemoglobin and

donation interval criteria for whole blood donors:

Projected impact on current donor base

Anne Eder, MD PhDExecutive Medical Officer

Blood Products Advisory Committee Meeting

July 27, 2010

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Four Questions

What would be the impact of changing the minimum predonation Hemoglobin (Hb) from 12.5 g/dL…

1. …to 13.0 g/dL for men? …to 13.5 g/dL for men?

2. …to 12.0 g/dL for women?

What would be the impact of changing the interdonation interval from 8 weeks (about 6-7 times per year) …..

3. ….to 12 weeks (about 4-5 times per year) for men?4. ….to 16 weeks (about 3-4 times per year) for women?

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Balance Sheet

Minimum Hemoglobin

Current Proposed Difference in Donations

Men12.5

13.0

13.5

Women 12.0

Donation Interval (Frequency)

Men

~ 6 -7

~4-5 (4.33)

Women~3-4

(3.25)

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Puerto Rico

Annual Data – (Denominator) 6 M Red Cells1.7 M Plasma Products 850,000 Apheresis Platelets 250,000 WB-derived Platelets 40,000 Pooled Platelets

American Red Cross, 2010

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Hb Distribution, Presenting Donors M

ale

Fem

ale

NHLBI Retrovirus Epidemiology Donor Study-II (REDS-II)New England Region, ARC, 2008-2009

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Question 1: Minimum Hb for Men

Number of Male PresentationsARC - CY2008

Projected additional deferral*

Change in Donations

3,883,345 3.78% - 146,790

Hb 12.5 → 13.0 g/dL for men

Hb 12.5 → 13.5 g/dL for men

3,883,345 9.96% - 386,781

*NHLBI Retrovirus Epidemiology Donor Study-II (REDS-II)New England Region, ARC, 2008-2009

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Question 2: Minimum Hb for Women

Total Female Presentations ARC - CY2008

Projected gain*

Change in Donations

3,987,923 4.97%

(Reduce Hb deferral by 40%)

+ 198,200

Hb 12.5 → 12.0 g/dL for women

*NHLBI Retrovirus Epidemiology Donor Study-II (REDS-II)New England Region, ARC, 2008-2009

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Questions 1&2: Minimum Hb

Male Donors

Current ProposedDifference in

Donations

Hb(g/dL) 12.5

13.0 - 146,790

13.5 - 386,781

Female Donors

Current ProposedDifference in

Donations

Hb(g/dL) 12.5 12.0 + 198,200

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Questions 3 & 4: Frequency

Number of Annual

Donations

Percentage of Donors Total Donations

Men Women Men Women

1 48.1% 50.6% 777,352 933,091

2 23.3% 25.4% 751,658 937,594

3 12.9% 13.1% 624,093 726,936

4 7.6% 6.5% 490,240 389,233

5 4.7% 3.0% 330,157 179,195

6 2.7% 1.1% 186,459 69,014

7 0.8% 0.2% 56,663 14,547American Red Cross, Cohort of CY2008 whole blood donors

followed for 365 days (6,466,231 donations)

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Questions 3 & 4: Frequency

Number of Annual

Donations

Percentage of Donors

Men Women

1 48.1% 50.6%

2 23.3% 25.4%

3 12.9% 13.1%

4 7.6% 10.8% donors

261,494 (7.4%)

donations*

5 8.2% donors

157,378 (4.7%) donations*

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7*Based on fractional estimates for frequency: 4.33 for men; 3.25 for women

American Red Cross, Cohort of CY2008 whole blood donors followed for 365 days (6,466,231 donations)

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Balance Sheet

Minimum Hemoglobin

Current Proposed Difference

in Donations

Percent Gain or

Loss

Men12.5

13.0 - 146,790 - 4%

13.5 - 386,781 - 10%

Women 12.0 +198,200 + 5%

Donation Interval (Frequency)

Men

~ 6 -7

~4-5 (4.33)

- 157,378 - 5%

Women~ 3-4(3.25)

- 261,494 - 7%

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Conclusions

In the ARC system, changing the minimum hemoglobin requirement to13.0 g/dL for men and 12.0 g/dL for women is predicted to have little effect on total collections

Changing the donation interval is predicted to have a significant, detrimental effect on collections

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Donation Frequency – Cohort

Day 1              Donation 1Day 57            Donation 2Day 113 Donation 3Day 169          Donation 4Day 225          Donation 5Day 281          Donation 6Day 337          Donation 7And 28 days left until New Years.

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Model Donation Interval

56 d0

= 6donations

56 d 56 d 56 d 56 d

Original Interval

New Interval

112 d0

= 3donations

112 d

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Donation Interval – Male Donors

Current

(56 days)

New

(84 days)

Donors 1,616,067 1,616,067

Total Donations 3,373,999 2,844,305

Return Donations 1,757,932 1,228,238

# Donations -529,694

% Donations -15.7%

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Donation Interval – Female Donors

Current

(56 days)

New

(112 days)

Donors 1,844,812 1,844,812

Total Donations 3,511,104 2,903,147

Return Donations 1,666,292 1,058,335

# Donations -607,957

% Donations -17.3%