Philip J Norris1,2,3, Zhanna Kaidarova1, Erica Maiorana4, Silvano Milani5, Mila Lebedeva1, Michael P Busch1,2, Brian Custer1,2, Paolo Rebulla6. 1. Blood Systems Research Institute. 2. Department of Laboratory Medicine, University of California-San Francisco. 3. Department of Medicine, University of California-San Francisco, San Francisco, California. 4. Italian National Blood Center, Rome, Italy. 5. Laboratory of Medical Statistics and Biometry, Department of Clinical Sciences and Community Health, University of Milan. 6. Department of Regenerative Medicine, Foundation IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy.
Abstract
BACKGROUND: The current study explored whether pathogen-reduction treatment of platelet components before transfusion would decrease the risk of alloimmunization. STUDY DESIGN AND METHODS: Study participants were patients with hematologic cancer who were included in two parallel, randomized clinical trials testing pathogen-reduction treatment versus conventional platelets using the Mirasol or Intercept pathogen-reduction systems. Patients who had a baseline, pretransfusion sample and a follow-up, posttransfusion sample were included in the study (n = 179 patients in each study arm). Human leukocyte antigen antibody levels were determined using a commercial multianalyte, bead-based assay. RESULTS: The rate of human leukocyte antigen Class I alloimmunization at the clinical sites in recipients of conventional platelets was low at the highest assay cutoff (range, 1.2%-5.9%). Consistent with prior studies, human leukocyte antigen antibodies were first detected from 3 to 35 days after transfusion. There were no statistically significant differences between alloimmunization rates in patients who received pathogen-reduction treatment versus conventional platelet transfusions. Although he difference was not statistically significant, the effect size for protection from alloimmunization was greatest for high-level human leukocyte antigen Class I antibodies (approximately threefold) in the Intercept-treated patients compared with those who received conventional platelets. In the Mirasol study, only two patients and one patient in the control group developed medium-level or high-level antibodies, respectively, so it was impossible to determine an effect size for potential protection. CONCLUSIONS: The current study was not sufficiently powered to determine whether pathogen-reduction treatment provides protection from human leukocyte antigen alloimmunization in platelet transfusion recipients. The data presented will be useful in the design of future trials and endpoints powered to detect a protective effect.
RCT Entities:
BACKGROUND: The current study explored whether pathogen-reduction treatment of platelet components before transfusion would decrease the risk of alloimmunization. STUDY DESIGN AND METHODS: Study participants were patients with hematologic cancer who were included in two parallel, randomized clinical trials testing pathogen-reduction treatment versus conventional platelets using the Mirasol or Intercept pathogen-reduction systems. Patients who had a baseline, pretransfusion sample and a follow-up, posttransfusion sample were included in the study (n = 179 patients in each study arm). Human leukocyte antigen antibody levels were determined using a commercial multianalyte, bead-based assay. RESULTS: The rate of human leukocyte antigen Class I alloimmunization at the clinical sites in recipients of conventional platelets was low at the highest assay cutoff (range, 1.2%-5.9%). Consistent with prior studies, human leukocyte antigen antibodies were first detected from 3 to 35 days after transfusion. There were no statistically significant differences between alloimmunization rates in patients who received pathogen-reduction treatment versus conventional platelet transfusions. Although he difference was not statistically significant, the effect size for protection from alloimmunization was greatest for high-level human leukocyte antigen Class I antibodies (approximately threefold) in the Intercept-treated patients compared with those who received conventional platelets. In the Mirasol study, only two patients and one patient in the control group developed medium-level or high-level antibodies, respectively, so it was impossible to determine an effect size for potential protection. CONCLUSIONS: The current study was not sufficiently powered to determine whether pathogen-reduction treatment provides protection from human leukocyte antigen alloimmunization in platelet transfusion recipients. The data presented will be useful in the design of future trials and endpoints powered to detect a protective effect.
Authors: Anno Saris; Ivan Peyron; Pieter F van der Meer; Tor B Stuge; Jaap Jan Zwaginga; S Marieke van Ham; Anja Ten Brinke Journal: Front Immunol Date: 2018-06-05 Impact factor: 7.561
Authors: Laura Infanti; Andreas Holbro; Jakob Passweg; Daniel Bolliger; Dimitrios A Tsakiris; Ramona Merki; Alexandra Plattner; David Tappe; Johannes Irsch; Jin-Sying Lin; Laurence Corash; Richard J Benjamin; Andreas Buser Journal: Transfusion Date: 2019-10-01 Impact factor: 3.157