Acute pulmonary injury in hematology patients supported with pathogen-reduced and conventional platelet components.
Allison P WheelerEdward L SnyderMajed RefaaiClaudia S CohnJessica PoissonMagali J FontaineMary SehlAjay K NookaLynne UhlPhilip C SpinellaMaly FenelusDarla LilesThomas CoyleJoanne BeckerMichael Raymond JengEric A GehrieBryan R SpencerPampee YoungAndrew JohnsonJennifer J O'BrienGary J SchillerJohn D RobackElizabeth MalynnRonald JackupsScott T AvecillaKathy LiuStanley BentowJeanne VarroneRichard J BenjaminLaurence M CorashPublished in: Blood advances (2024)
Patients treated with antineoplastic 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 (PRPCs) do not potentiate pulmonary dysfunction compared with conventional platelet components (CPCs). A prospective, multicenter, 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 and 1223 CPC) was less for PRPC (1.7 %) than CPC (3.1%) with a treatment difference of -1.5% (95% confidence interval [CI], -2.7 to -0.2). In patients requiring ≥2 PCs, the incidence of TEAMV-PD was reduced for PRPC recipients compared with CPC recipients (treatment difference, -2.4%; 95% CI, -4.2 to -0.6). CSPAE increased with increasing PC exposure but were not significantly different between the cohorts. For patients receiving ≥2 platelet transfusions, TEARDS occurred in 1.3% PRPC and 2.6% CPC recipients (P = .086). Bayesian analysis demonstrated PRPC may be superior in reducing TEAMV-PD and TEARDS for platelet transfusion recipients compared with CPC recipients, with 99.2% and 88.8% probability, respectively. In this study, PRPC compared with CPC demonstrated high probability of reduced severe pulmonary injury requiring assisted mechanical ventilation in patients with hematology disorders dependent on platelet transfusion. This trial was registered at www.ClinicalTrials.gov as #NCT02549222.
Keyphrases
- mechanical ventilation
- acute respiratory distress syndrome
- end stage renal disease
- pulmonary hypertension
- chronic kidney disease
- ejection fraction
- intensive care unit
- open label
- risk factors
- peritoneal dialysis
- clinical trial
- oxidative stress
- prognostic factors
- cardiac surgery
- extracorporeal membrane oxygenation
- stem cells
- type diabetes
- mesenchymal stem cells
- combination therapy
- kidney transplantation
- acute kidney injury
- study protocol
- risk assessment
- phase ii
- patient reported outcomes
- skeletal muscle
- rectal cancer
- smoking cessation