Hemostatic efficacy of pathogen-inactivated vs untreated platelets: a randomized controlled trial

Abstract

Pathogen inactivation of platelet concentrates reduces the risk for blood-borne infections. However, its effect on platelet function and hemostatic efficacy of transfusion is unclear. We conducted a randomized noninferiority trial comparing the efficacy of pathogen-inactivated platelets using riboflavin and UV B illumination technology (intervention) compared with standard plasma-stored platelets (control) for the prevention of bleeding in patients with hematologic malignancies and thrombocytopenia. The primary outcome parameter was the proportion of transfusion-treatment periods in which the patient had grade 2 or higher bleeding, as defined by World Health Organization criteria. Between November 2010 and April 2016, 469 unique patients were randomized to 567 transfusion-treatment periods (283 in the control arm, 284 in the intervention arm). There was a 3% absolute difference in grade 2 or higher bleeding in the intention-to-treat analysis: 51% of the transfusion-treatment periods in the control arm and 54% in the intervention arm (95% confidence interval [CI], -6 to 11; = .012 for noninferiority). However, in the per-protocol analysis, the difference in grade 2 or higher bleeding was 8%: 44% in the control arm and 52% in the intervention arm (95% CI -2 to 18; = .19 for noninferiority). Transfusion increment parameters were ∼50% lower in the intervention arm. There was no difference in the proportion of patients developing HLA class I alloantibodies. In conclusion, the noninferiority criterion for pathogen-inactivated platelets was met in the intention-to-treat analysis. This finding was not demonstrated in the per-protocol analysis. This trial was registered at The Netherlands National Trial Registry as #NTR2106 and at www.clinicaltrials.gov as #NCT02783313.

Storage-Induced Platelet Apoptosis Is a Potential Risk Factor for Alloimmunization Upon Platelet Transfusion

“…This, however, may be explained by the fact that these only use fresh platelets ( 55 , 56 ), while pathogen reduction did not affect platelet internalization directly after treatment, but rather enhanced the storage-mediated internalization. Interestingly, two clinical trials were recently published that may confirm this hypothesis ( 57 , 58 ). Namely, one of these studies stored platelets on average for 1 day and showed a protective effect of pathogen inactivation ( 58 , 59 ), whereas the other trial stored platelets on average for 4 days and did not show any protective effect of pathogen inactivation ( 57 ).…”

“…Interestingly, two clinical trials were recently published that may confirm this hypothesis ( 57 , 58 ). Namely, one of these studies stored platelets on average for 1 day and showed a protective effect of pathogen inactivation ( 58 , 59 ), whereas the other trial stored platelets on average for 4 days and did not show any protective effect of pathogen inactivation ( 57 ).…”

How do you… decide which platelet bacterial risk mitigation strategy to select for your hospital‐based transfusion service?

“…12 Concerns expressed regarding the use of PRPs include the potential need for maintaining a dual inventory of platelets due to supply limitations, decreased platelet count increments (PCIs), 13 risk of human leukocyte antigen (HLA) alloimmunization, 14 and the effect of psoralen on neonatal, pediatric, and obstetric patients. [15][16][17] Even with noninferior hemostatic function in hematology oncology patients, 18,19 decreased PCIs may result in increased platelet utilization and reduced platelet inventory. Increased HLA alloimmunization 14 may make finding suitable platelet products more difficult, an additional challenge for TSPs and clinicians.…”

Vitamin B2 and Innovations in Improving Blood Safety

“…The CCI at one and 24 h after transfusion is decreased in patients receiving PRT treated products, compared to patients receiving control products. In two recent clinical trials Grade 2 or higher bleeding was the primary endpoint [55,66].…”