Transfusion of pathogen‐reduced platelet components without leukoreduction

Abstract

BACKGROUNDLeukoreduction (LR) of platelet concentrate (PC) has evolved as the standard to mitigate risks of alloimmunization, clinical refractoriness, acute transfusion reactions (ATRs), and cytomegalovirus infection, but does not prevent transfusion‐associated graft‐versus‐host disease (TA‐GVHD). Amotosalen–ultraviolet A pathogen reduction (A‐PR) of PC reduces risk of transfusion‐transmitted infection and TA‐GVHD. In vitro data indicate that A‐PR effectively inactivates WBCs and infectious pathogens.STUDY DESIGN AND METHODSA sequential cohort study evaluated A‐PR without LR, gamma irradiation, and bacterial screening in hematopoietic stem cell transplant (HSCT) recipients. The first cohort received conventional PC (control) processed without LR, but with gamma irradiation and bacterial screening. The second cohort received A‐PR PC (test) processed without: LR, bacterial screening, or gamma irradiation. The primary efficacy outcome was the 1‐hour corrected count increment. The primary safety outcome was treatment‐emergent ATR. Secondary outcomes included clinical refractoriness, and 100‐day status for engraftment, TA‐GVHD, HSCT‐GVHD, infections, and mortality.RESULTSMean corrected count increment (× 103) of 33 test PC recipients was similar (18.9 ± 8.8 vs. 16.6 ± 8.4; p = 0.296) to that of 31 control PC recipients. Test recipients had a reduced, but nonsignificant, incidence of ATR (test = 9.1%, Control = 19.4%; p = 0.296). The frequencies of clinical refractoriness (0 of 33 vs. 4 of 31 patients) and refractory transfusions (6.6% vs. 19.3%) were lower in the test cohort (p = 0.05 and 0.02), respectively. No patient in either cohort had TA‐GVHD. Day 100 engraftment, HSCT‐GVHD, mortality, and infectious disease complications were similar between cohorts.CONCLUSIONSThis study indicated that A‐PR PC without LR, gamma irradiation, or bacterial screening is feasible for support of HSCT.

Human platelets labeled at two discrete biotin densities are functional in vitro and are detected in vivo in the murine circulation: A promising approach to monitor platelet survival in vivo in clinical research

“…The procedures for the production and storage of platelet concentrates (PCs) intended for transfusion are continually evolving with the use of novel pathogen-reduction technologies, new platelet (PLT) additive solutions, extended conditions of storage, and improved preparation methods and devices. [1][2][3][4][5][6][7][8][9] These new strategies enhance the safety of the recipients and help to optimize utilization of blood reserves, human and technical resources, and management of the PLT supply.…”

The 4-Year Experience with Implementation and Routine Use of Pathogen Inactivation in a Brazilian Hospital

“…We were able to take advantage of these benefits, thus balancing the costs of PI. A direct combination of both was attained at our institution by: 1) replacing selective testing such as cytomegalovirus serology; 2) reducing the need for additional blood screening tests such as bacterial screening of PC [13]; 3) replacing gamma irradiation to prevent TA-GVHD [32,33,34]; and 4) reducing the frequency of platelet transfusion reactions [35,36]. Indeed, the INTERCEPT Blood System, which has a high inactivation efficacy for bacteria, has been recognized by the FDA as an alternative to complex culture-based screening algorithms [5,37,38,39,40,41,42].…”

Inactivation of a broad spectrum of viruses and parasites by photochemical treatment of plasma and platelets using amotosalen and ultraviolet A light

“…While this review focused on the inactivation of viruses and parasites, the amotosalen/UVA PRT has proven efficacy to prevent transfusion‐associated graft‐versus‐host disease and bacterial TTIs, the most significant infectious risk in transfusion today . PRT is now considered an alternative to bacterial screening, irradiation, and CMV testing .…”