Reduce Patient Risk of Transfusion-Associated Sepsis

Reducing the Risk of TA-GVHD:

Transfusion-Associated Graft-versus-Host Disease (TA-GVHD) is a rare complication in which the viable T cells from the donor engraft and subsequently attacks the recipient’s cells. TA-GVHD is generally thought to occur only in immuno-compromised patients, but there are cases reported in immunocompetent individuals.^1,2

Ability to reduce the risk of TA-GVHD is based on halting T-cell replication either by:

• Leukofiltration (considered ineffective based on case reports of TA-GVHD with leukoreduced products)³
• Contaminating T-cell reduction
  • Irradiation⁴
  • INTERCEPT treatment⁶

Irradiation has been approved for many years as a means to reduce TA-GVHD risk. However, T-cell activity studies have shown that gamma irradiation only partially inhibits markers of activity, mainly cytokine accumulation.  In the same study, pathogen reduction eliminated this cytokine accumulation.⁵

Figure: Comparison between gamma irradiation and psoralen/UVA treatment.^6,7

FDA and AABB Standard 5.19.3.1 accept INTERCEPT as an alternative to gamma irradiation for the prevention of TA-GVHD*.^8,9

AABB Standards for Prevention of TA-GVHD

AABB standard 5.19.3.1 cites the “acceptable methods known to prevent transfusion-associated graft-vs-host disease include irradiation and pathogen reduction technology known to inactivate residual leukocytes that is cleared or approved by the FDA or Competent Authority.”⁸

1. McMilin, K. and R. Johnson, HLA homozygosity and the risk of related-donor transfusion-associated graft-versus-host disease. Transfus Med Rev, 1993. 7(1): p. 37-41.
2. Thaler , M., et al., The Role of Blood from HLA-Homozygous Donors in Fatal Transfusion-Associated Graft-versus-Host Disease after Open-Heart Surgery. New England Journal of Medicine, 1989. 321(1): p. 25-28.
3. Kopolovic, I., et al., A systematic review of transfusion-associated graft-versus-host disease. Blood, 2015. 126(3): p. 406-14.
4. AABB. Circular of Information for the Use of Human Blood and Blood Components. Bethesda, MD: AABB; 2017
5. Hei, D.J., et al., Elimination of cytokine production in stored platelet concentrate aliquots by photochemical treatment with psoralen plus ultraviolet A light. Transfusion, 1999. 39(3): p. 239-48.
6. Grass JA, Hei DJ, Metchette K, et al. Inactivation of leukocytes in platelet concentrates by photochemical treatment with psoralen plus UVA. Blood 1998;91:2180-8.
7. Setlow R, Setlow J. Effects of radiation on polynucleotides. Annu Rev Biophys Bioeng 1972;1:293-346.
8. The INTERCEPT Blood System for Platelets Package Insert, Cerus Corporation; July 17, 2018.
9. “Standards for Blood Banks and Transfusion Services,” AABB, 31th edition, 2018.