Acute Pulmonary Injury in Hematology Patients Supported with Pathogen Reduced and Conventional Platelet Components.

Patients treated with anti-neoplastic therapy often develop thrombocytopenia requiring platelet transfusion which has potential to exacerbate pulmonary injury. This study tested the hypothesis that amotosalen-UVA pathogen reduced platelet components (PRPC) do not potentiate pulmonary dysfunction compared to conventional platelet components (CPC). A prospective, multi-center, open label, sequential cohort study evaluated the incidence of treatment emergent assisted mechanical ventilation initiated for pulmonary dysfunction (TEAMV-PD). The first cohort received CPC. After the CPC cohort, each site enrolled a second cohort transfused with PRPC. Other outcomes included clinically significant pulmonary adverse events (CSPAE), and the incidence of treatment emergent acute respiratory distress syndrome (TEARDS) diagnosed by blinded expert adjudication. The incidence of TEAMV-PD in all patients (1068 PRPC, 1223 CPC) was less for PRPC (1.7 %) than CPC (3.1%) with a treatment difference = -1.5%, 95% CI: (-2.7%, -0.2%). In patients requiring ≥ 2 PC the incidence of TEAMV-PD was reduced for PRPC recipients compared to CPC (treatment difference = -2.4%, 95% CI: (-4.2%, -0.6%). CSPAE increased with increasing PC exposure; but were not significantly different between the cohorts. For patients receiving 2 or more platelet transfusions, TEARDS occurred in 1.3% PRPC and 2.6 % CPC recipients, p = 0.086. Bayesian analysis demonstrated PRPC may be superior in reducing TEAMV-PD and TEARDS for platelet transfusion recipients compared to CPC with 99.2% and 88.8% probability, respectively. In this study, PRPC compared to CPC demonstrated high probability of reduced severe pulmonary injury requiring assisted mechanical ventilation in platelet transfusion dependent hematology patients. CT # NCT02549222.