학술논문

Proceedings of the Food and Drug Administration public workshop on pathogen reduction technologies for blood safety 2018 (Commentary, p. 3026).
Document Type
Historical Material
Source
Transfusion. Sep2019, Vol. 59 Issue 9, p3002-3025. 24p. 4 Charts, 1 Graph.
Subject
*BLOOD transfusion reaction
*PUBLIC administration
*NEEDLE exchange programs
*SARS disease
Language
ISSN
0041-1132
Abstract
The first day of the workshop focused on blood-borne infectious agents and their impact on blood safety, experiences of the American Red Cross, and other blood establishments in implementing FDA-approved pathogen inactivation (PI) technology for plasma and platelets (PLTs) in the United States and novel PRTs under consideration for whole blood (WB) and red blood cells (RBCs). 3 ‡ Retention rate of platelets after the PRT process (mean ± standard deviation; number of PRT platelet products tested for quality assurance to document the loss of platelets) n/a - not applicable. There are still unknowns with respect to the use of PI-treated PLTs in actively bleeding patients, particularly those with massive hemorrhage.[55] Whether use of large volumes of PI-treated products, including PI-treated PLTs will amplify the negative effect of PI on PLT efficacy and overall hemostasis remains to be determined. Estcourt and colleagues, summarizing meta-analyses for 12 clinical trials with these products, indicated that "We found moderate-quality evidence that pathogen-reduced platelet transfusions do not affect all-cause mortality, the risk of clinically significant or severe bleeding, or the risk of a serious adverse event."[[132]] The authors also noted that, "We found high-quality evidence that pathogen-reduced platelet transfusions increase the risk of platelet refractoriness and the platelet transfusion requirement." The DOD has invested significant resources into the development of PRT to improve the safety of blood transfusion on the battlefield.[178] In addition to the need to reduce the risk of bacterial contamination associated with room temperature storage of PLTs, the unique challenges of combat casualty care include the need to collect WB and PLTs in remote deployed environments and transfuse these products before the availability of transfusion-transmitted disease testing results. [Extracted from the article]