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. 2019 Jun;59(6):1953-1961.
doi: 10.1111/trf.15269. Epub 2019 Mar 28.

Transfusion of pathogen-reduced platelet components without leukoreduction

Joycelyn Sim  1 , Wai Chiu Tsoi  2 , Cheuk Kwong Lee  2 , Rock Leung  1 , Clarence C K Lam  1 , Claudia Koontz  3 , Amy Yingjie Liu  3 , Norman Huang  3 , Richard J Benjamin  3 , Hans J Vermeij  3 , Adonis Stassinopoulos  3 , Laurence Corash  3 , Albert K W Lie  1
Affiliations

Transfusion of pathogen-reduced platelet components without leukoreduction

Joycelyn Sim et al. Transfusion. 2019 Jun.

Abstract

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.

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Conflict of interest statement

JS, WCT, CKL, RL, CCKL, and AKWL have disclosed no conflicts of interest. Cerus Corporation, manufacturer of the INTERCEPT Blood Systems for Platelets, provided institutional research support for performance of the study. CK, AYL, NH, RJB, HJV, AS, and LC are employees of Cerus Corporation and beneficial owners of Cerus equities or options during the conduct of this study, analysis of the data, and preparation of the manuscript. JS, WCT, CKL, RL, CCKL, and AKWL conducted the clinical study. JS, WCT, and AKWL determined the scope and design of the study. CK and AYL monitored study data. NH designed the data collection methods and performed the biostatistics analysis. HJV transferred the A‐PR technology and the production of whole blood–derived buffy coat PC to the HKRCBTS. AS cowrote the clinical protocol, monitored PC production, and coordinated interactions with the sponsor. RJB reviewed study data and edited the manuscript. LC wrote the clinical trial protocol, reviewed clinical data, and wrote the manuscript.

Figures

Figure 1
Figure 1
Mean 1‐hour CCI responses for test and control cohort patients during the active transfusion period. Data and number of patients (n) are presented for all patients, allogeneic HSCT test and control patients with GVHD(+), for allogeneic HSCT test and control patients without GVHD(−), and for autologous HSCT test and control patients. Mean values are represented by the ▴, median values are represented by the bar, and the interquartile ranges with outliers are indicated.
See this image and copyright information in PMC

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