A colleague in Sacramento requests input from the e-Network Forum regarding what others do with donors implicated in TRALI, and those at high risk of causing TRALI.

ADDENDA July 30, 2004

1. Editor's Note: Please note the News Item from July 30, 2004 AABB Weekly Report: Blood Community, FDA Move Toward Definition of TRALI, indicating that the FDA is considering three possible regulatory actions regarding donor management strategies if supported by adequate scientific data.

ADDENDA June 3, 2005

2. Editor's Note: AABB issued Association Bulletin #05-06: Final Interim Standard for Standards for Blood Banks and Transfusion Services (23rd edition) on June 3, 2005. This bulletin contains the final wording of an interim standard that addresses the management of donors implicated in or associated with cases of transfusion-related acute lung injury (TRALI). Note: Association Bulletin 05-06 is no longer available on the AABB website.

ADDENDA Nov. 15, 2006

3. Editor's Note: AABB issued Association Bulletin #06-07: Transfusion-Related Acute Lung Injury on Nov. 3, 2006, which is intended to provide recommendations to further reduce the risk of TRALI in blood and blood component recipients. This bulletin does not change the requirements relating to Standard 5.4.2.1 in the 24th edition of Standards for Blood Banks and Transfusion Services. As noted in the bulletin, the board of directors has adopted recommendations of the AABB TRALI Working Group to reduce the incidence of TRALI.

ADDENDA Jan. 26, 2007

4. Dr. Paul Schmidt, an experienced blood banker (attribution used with permission) recalls an event in 'what goes around comes around, sometimes backwards' relative to the non-use of female plasma to prevent TRALI. Paul reports that a proposal was made at an NIH meeting in the early 1980s by a lady representing a public group that wanted only women to be accepted as blood donors. Their premise was in that way the frightening disease we came to know as AIDS would not be transmitted by transfusion.

ADDENDA Jan. 29,2007

5. According to a Quality Manager at a Blood and Tissue Bank in Spain, when dealing with TRALI, they acknowledge that without a clear knowledge of its physiopathology, their efforts to curtail TRALI will probably fall short. For example, they know of strategies to avoid anti-leukocyte antibodies, but they do not yet know how to avoid immunologically active lipids.

Their strategy is as follows:

1. They defer all donors who are clearly implicated in TRALI episodes. That is, clinical probability for TRALI (Canadian consensus) and anti-HLA Class I/II antibodies in donor's plasma.
   
   
2. To reduce patient's exposure to HLA antibodies, they manage donors as follows:
   
   
   1. Apheresis: they test for anti-HLA Class I/II antibodies in all women with previous pregnancies. Those with positive results donate only plasma that is sent to the plasma fractioning industry.
      
      
   2. Whole blood donors:

• They prepare plasma or cryoprecipitate for transfusion only from men or from women without previous pregnancies.
• Plasma from women with previous pregnancies is sent to the fractioning industry.
• Women are queried at every blood donation for their pregnancy status. Donor records, and blood collection bags are flagged according to that status.
• They prepare platelets from buffy coats in additive solution. Thus, they reduce the donor's plasma content in platelets.
• Furthermore, when preparing platelet pools, they try to avoid buffy coats donated by women with two or more pregnancies.
• The buffy coat preparation tecnology allows the production of red cell concentrates with a much lower plasma content.

As far as they know, there have been no protests from their donors.

ADDENDA Feb. 5, 2007

6. A colleague at a hospital in Seattle reports that they perform a triple blood volume exchange transfusion prior to ABO mismatched heart transplants for infants who have anti-A and/or anti-B titers that are reactive against the transplanted organ. In addition, they occasionally perform plasmapheresis for HLA sensitized solid organ transplant patients. She asks "Should the plasma used for these procedures only be from male donors?" Finally, she asks if it is intuitive that the concern regarding the heart transplant infant is about passively transferring HLA antibodies from the blood donors to the recipient?

ADDENDA Feb. 26, 2007

7. The medical director of a Midwestern hospital-based donor center comments that her institution is considering a strategy of querying women about their pregnancy history and not using the plasma of any woman who has ever been pregnant. This approach is somewhat similar to that described by the Spanish colleague in the January 29, 2007 posting to this discussion. However, their internal discussions have raised several questions, including how can one be sure a woman has never been pregnant? They have envisioned several scenarios, including:

1. a woman may have had an abortion and did not want to report it
2. a woman may not consider a miscarriage as a pregnancy
3. a woman may not know she had been pregnant when she miscarried

The inquiring physician thinks the likelihood of alloimmunization to HLA and HNA antigens is very low in early pregnancy. She wonders what other institutions are doing to comply with the new AABB recommendations that were issued in AABB Association Bulletin #06-07 on Nov. 3, 2006. According to the bulletin, the AABB board of directors adopted the following recommendations to reduce the incidence of TRALI:

• Blood collecting facilities should implement interventions to minimize the preparation of high plasma-volume components from donors known to be leukocyte-alloimmunized or at increased risk of leukocyte alloimmunization.
• Blood transfusion facilities should work towards implementing appropriate evidence-based hemotherapy practices in order to minimize unnecessary transfusion.
• Blood collection and transfusion facilities should monitor the incidence of reported TRALI and TRALI-related mortality.

She is most concerned that if all women platelet donors were to be deferred, the supply of platelets would fall to critical levels.

Please submit comments to the e-Network Forum.

Ira A. Shulman, MD
CBBS e-Network Forum Editor & Moderator

W. Tait Stevens, MD
CBBS e-Network Forum Assistant Editor & Moderator