Transfusion of pathogen‐reduced platelet components without leukoreduction

• Published in: Transfusion (Philadelphia, Pa.) Vol. 59; no. 6; pp. 1953 - 1961
• Main Authors: Sim, Joycelyn, Tsoi, Wai Chiu, Lee, Cheuk Kwong, Leung, Rock, Lam, Clarence C. K., Koontz, Claudia, Liu, Amy Yingjie, Huang, Norman, Benjamin, Richard J, Vermeij, Hans J., Stassinopoulos, Adonis, Corash, Laurence, Lie, Albert K. W.
• Format: Journal Article
• Language: English
• Published: Hoboken, USA John Wiley & Sons, Inc 01.06.2019; Wiley Subscription Services, Inc
• Subjects: Adult; Antisepsis - methods; Bacteria; Blood Platelets - cytology; Blood-Borne Pathogens - isolation & purification; Case-Control Studies; Cohort Studies; Complications; Cytomegalovirus; Disinfection - methods; Female; Furocoumarins; Gamma irradiation; Gamma Rays; Graft vs Host Disease - epidemiology; Graft vs Host Disease - etiology; Graft-versus-host reaction; Health risks; Hematopoietic stem cells; Humans; Infections; Infectious diseases; Irradiation; Isoimmunization; Leukocyte Count; Leukocytes - cytology; Male; Middle Aged; Mortality; Pathogens; Patients; Platelet Transfusion - adverse effects; Platelet Transfusion - methods; Platelet Transfusion - standards; Platelets; Screening; Stem cell transplantation; Stem cells; Thermal resistance; Transfusion; Transfusion Medicine; Transfusion Reaction - blood; Transfusion Reaction - epidemiology; Transfusion Reaction - prevention & control; Ultraviolet Rays; Virus Inactivation - drug effects; Virus Inactivation - radiation effects
• ISSN: 0041-1132; 1537-2995
• DOI: 10.1111/trf.15269

BACKGROUND Leukoreduction (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 METHODS A 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. RESULTS Mean 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. CONCLUSIONS This study indicated that A‐PR PC without LR, gamma irradiation, or bacterial screening is feasible for support of HSCT.