Organ System Bleeding in the PLADO Trial

Abstract

In the multi-institutional platelet dose trial (PLADO Trial), there were 1,077 hematology/oncology patients ≥18 years of age who received at least one platelet transfusion. These patients were analyzed for types and severity of organ system bleeding based on baseline patient characteristics, laboratory assays, primary diagnosis, and type of treatment. Patients were randomly assigned to receive one of three different prophylactic platelet doses for morning platelet counts of ≤10 × 109 /L. Daily assessments of bleeding in nine organ systems were performed and bleeding severity was based on a WHO bleeding scale. For the purposes of analyses, Grade 2A bleeding was defined to be WHO Grade 2 bleeding that was not solely due to purpura. Grade 2A or greater bleeding occurred in 616 patients (57.2%) on 13.3% of study days predominately in the GI (31.2% of patients on 4.4% of days), GU (21.1% of patients on 5.1% of days), pulmonary (17.6% of patients on 2.7% of days), and oral/nasal systems (14.6% of patients on 2.0% of days). Grade 3 or greater bleeding occurred in 102 patients (9.5%) on 0.8% of study days. CNS bleeding occurred in 2.7% of patients on 0.2% of study days and was independent of platelet count. Treatment stratum (ALLO, CHEMO, AUTO) impacted degree of bleeding and onset; and distribution of involved organs systems. Secondary analyses of the PLADO Trial patient data, the largest patient dataset curated to date, showed that patients with hypoproliferative thrombocytopenia experience significant bleeding in multiple organ systems, which varies by treatment group, but is independent of platelet dose.