The Crossover of Directed Donations

1
The Crossover of Directed Donations

• Nadine Shehata, Heather Hume, Dale Towns, Barbara
  Hannach
• Canadian Blood Services

2
Directed Donations Overview

• Background of the current program
• Rationale for the crossover of directed donations
  
• Proposals for changes to the current policy
• Policies at regulatory and blood services agencies

3
Background

• Program instituted in 1996
• All CBS centres offer the program
• Restricted program- donation is only permitted
• for medical indications
• from a parent/guardian to a child under the age
  of 18 years

4
Background

• Compatibility is pre-determined at hospitals
• Only parents who are compatible donate
• A unit not used by the intended recipient is
  discarded

5
Proposed Changes to Expand the Directed Donation
Policy

• CBS is submitting to Health Canada a proposal to
  expand the directed donations program
• CBSs directed donations program would then be
  similar to Hema-Quebecs program

6
Proposed Changes in Policy Cross-Over of
Directed Donations

• Crossover of a directed donation not compatible
  or not used by the recipient
• Donors will meet all the eligibility criteria for
  allogeneic donations, except for the limited
  exposure program frequency of donation may be
  less than 56 days

7
Transfusion Transmissible Disease Markers

• Transfusion-transmissible disease markers were
  collected from 10 CBS centres from 1997-2000
• 2,618 donations from 1,884 donors
• Confirmed positive markers compared to allogeneic
  markers (1999)

8
Transfusion Transmissible Disease Markers in
Directed Donations (1997-2000) Compared to All
Allogeneic Donations (1999) Canadian Blood
Services
HIVhuman immunodeficiency virus, HTLVhuman
T-lymphotropic virus
9
Transfusion Transmissible Disease Markers in
Directed Donations (1997-2000) Compared to First
Time and Repeat Allogeneic Donations (1999)
Canadian Blood Services
FADfirst time allogeneic donation, RADrepeat
allogeneic donation, HIVhuman immunodeficiency
virus, HTLVhuman T- lymphotropic virus
10
Transfusion-Transmissible Disease Markers in the
United States1987-1988
Starkey JM et al. JAMA 1989 2623452
11
Transfusion-Transmissible Disease Markers in
Australia 1990-1995
Petz L et al. Trans Med 1995 5159-163.
12
Hospital Utilization for Allogeneic and
Directed Donations
FYfiscal year
13
Rationale for the Crossover of Directed Donations

• Directed donations are not less safe (nor safer)
  than other allogeneic donations.
• To optimize utilization
• To potentially increase the number of allogeneic
  donors

14
The Crossover of Directed Donations for an
Expanded Program Proposal
Compatibility not pre-determined
Directed donation
Not Compatible
Compatible
Directed Recipient
Not required
Crossover
Crossover
15
Logistics

• CBS centres
• CBS Head Office
• Hospital Transfusion Medicine

16
Information Brochure

• To be amended for the physician, donor and
  recipient
• Will include additional information on
• compatibility testing
• irradiation of units from a relative
• potential for crossover

17
Amendments to Current Consent Forms
Donor
Recipient

• Potential for crossover if not compatible
• Potential for crossover if the unit is not
  required

• Potential for crossover if unit is not compatible
  or unit is not required
• Acceptance of directed donors units
• Irradiation of a unit from a relative

18
Projected Yield

• Current program
• An additional 200-400 red cell units/year
• Expanded program
• An additional 300-600 red cell units/ year

19
Crossover of Directed Donations Regulatory
Agencies
20
Crossover of Directed Donations Blood Services
Agencies
21
Crossover of Directed Donations Blood Services
Agencies
22
Proposal for the Crossover of Directed Donations
Summary

• Confirmed positive transfusion-transmissible
  disease markers for directed donation at CBS are
  similar to markers in the United States and
  Australia
• Discard rates for directed donations are
  considerably higher than allogeneic donations

23
Proposal for the Crossover of Directed Donations
Summary

• The CBS proposal to allow donors to donate
  before compatibility testing and crossover units
  that are not compatible or not used, has the
  potential of optimizing utilization, and
  increasing the number of allogeneic donors