Patient outcomes and amotosalen/UVA‐treated platelet utilization in massively transfused patients

Abstract

Background Amotosalen/UVA-treated platelet concentrates (PCs) have demonstrated efficacy for treating and preventing bleeding in clinical trials and in routine use; however, most studies were performed in haematology/oncology patients. We investigated efficacy during massive transfusion (MT) in general hospitalized patients.Methods Universal amotosalen/UVA treatment (INTERCEPT Blood System) of platelets was introduced at a large Austrian medical centre. We performed a retrospective cohort analysis comparing component use, in-hospital mortality and length of stay after MT that included platelet transfusion, for two periods (21 months each) before and after implementation.Results A total of 306 patients had MT. Patients were mostly male (74%) and ≥18 years old (99%), including 93 liver transplant, 97 cardiac or vascular surgery and 51 trauma patients. There were no differences in demographics between the periods. Component use on the day and within 7 days of the MT event was unchanged post-IBS implementation, except trauma patients received fewer RBCs on the day. The mean ratio of RBC:platelets:plasma on the day of the MT was close to 1:1:1 in both periods, except for liver transplants with MT who received more plasma components. Overall, in-hospital mortality (preimplementation = 27Á6% vs. postimplementation = 24Á0%; P = 0Á51) and median time to discharge (preimplementation = 27 vs. postimplementation = 23 days; P = 0Á37) did not change, except for cardiac and vascular surgery patients who were discharged earlier. ConclusionThe introduction of amotosalen/UVA-treated, pathogen-reduced PC did not adversely affect clinical outcomes in massively transfused patients in terms of blood product usage, in-hospital mortality and length of stay for a range of clinical indications for platelet transfusion support.

How do we … integrate pathogen reduced platelets into our hospital blood bank inventory?

“…Similarly, data on product usage per patient are necessary to document the efficacy of PR PLTs. Data addressing these points have been published by our group [37][38][39] and others [19][20][21][22][23][24][34][35][36]40 providing evidence supporting the concept that diminishing the infectious risk by crosslinking nucleic acids does not negatively impact PLT activation or hemostatic efficacy. Other studies, however, including the EFFIPAP trial have also addressed this issue.…”

“…[14][15][16][17][18] Psoralen-based PR techniques have been utilized in Europe for many years, and multiple published studies support the benefits and safety of PR products. [19][20][21][22][23][24] Phase III clinical trials are also ongoing for riboflavin (MIPLATE) and UV-C light-based PR techniques for PLTs (CAPTURE). 4,25,26 PR systems are also currently available for plasma and cryoprecipitate.…”

The long and winding road to pathogen reduction of platelets, red blood cells and whole blood

“…Plasma PRTs, which have been reviewed by Seltsam and M€ uller (2013), will not be discussed here, as plasma is infrequently required for the treatment of haematological transfusion recipients. Specific information and speculations on the use of blood components treated with PRTs in massive transfusion protocols and trauma resuscitation can be found in other recent publications (Hess et al, 2016;Mays & Hess, 2017;Arbaeen et al, 2017;Nussbaumer et al, 2017;Thomas et al, 2019).…”

Implications of the US Food and Drug Administration draft guidance for mitigating septic reactions from platelet transfusions

“…Hemovigilance data demonstrate a low rate of adverse events with PR platelets, 12 and some studies fail to demonstrate increased bleeding or worse clinical outcomes for patients treated with PR platelets. 13,14 However, studies have shown an association between PR platelets and a reduction in 1-and 24-hour corrected count increments, increase in platelet refractoriness, decrease in time to next transfusion, and increase in platelet use. [15][16][17] The most recent study demonstrated a 50% increase in platelets transfused and a 25% increase in red blood cells transfused in patients receiving INTERCEPT vs control platelets.…”