title: Transfusion of prion-filtered red cells does not increase the rate of alloimmunization or transfusion reactions in patients: results of the UK trial of prion-filtered versus standard red cells in surgical patients (PRISM A).
abstract: This study, conducted for the UK Blood Transfusion Services (UKBTS), evaluated the clinical safety of red cells filtered through a CE-marked prion removal filter (P-Capt™). Patients requiring blood transfusion for elective procedures in nine UK hospitals were entered into a non-randomized open trial to assess development of red cell antibodies to standard red cell (RCC) or prion-filtered red cell concentrates (PF-RCC) at eight weeks and six months post-transfusion. Patients who received at least 1 unit of PF-RCC were compared with a control cohort given RCC only. About 917 PF-RCC and 1336 RCC units were transfused into 299 and 291 patients respectively. Twenty-six new red cell antibodies were detected post-transfusion in 10 patients in each arm, an overall alloimmunization rate of 4.4%. Neither the treatment arm [odds ratio (OR) 0.93, 95% confidence interval (CI) 0.3, 2.5] nor number of units transfused (OR 0.95, 95% CI 0.8, 1.1) had a significant effect on the proportion of patients who developed new alloantibodies. No pan-reactive antibodies or antibodies specifically against PF-RCC were detected. There was no difference in transfusion reactions between arms, and no novel transfusion-related adverse events clearly attributable to PF-RCC were seen. These data suggest that prion filtration of red cells does not reduce overall transfusion safety. This finding requires confirmation in large populations of transfused patients.
authors.affiliation: Department of Haematology, King's College Hospital, London, UK. dupe.elebute@nhs.net
authors.forename: Modupe O
authors.initials: MO
authors.lastname: Elebute
authors.forename: Louise
authors.initials: L
authors.lastname: Choo
authors.forename: Ana
authors.initials: A
authors.lastname: Mora
authors.forename: Coral
authors.initials: C
authors.lastname: MacRury
authors.forename: Charlotte
authors.initials: C
authors.lastname: Llewelyn
authors.forename: Shilpi
authors.initials: S
authors.lastname: Purohit
authors.forename: Vicky
authors.initials: V
authors.lastname: Hicks
authors.forename: Caroline
authors.initials: C
authors.lastname: Casey
authors.forename: Moira
authors.initials: M
authors.lastname: Malfroy
authors.forename: Alison
authors.initials: A
authors.lastname: Deary
authors.forename: Tania
authors.initials: T
authors.lastname: Reed
authors.forename: Sarah
authors.initials: S
authors.lastname: Meredith
authors.forename: Lynn
authors.initials: L
authors.lastname: Manson
authors.forename: Lorna M
authors.initials: LM
authors.lastname: Williamson
mesh_terms: D000327:Adsorption; D000368:Aged; D000369:Aged, 80 and over; D001789:Blood Group Antigens / Q000276:immunology; D001787:Blood Group Incompatibility / Q000453:epidemiology / Q000209:etiology; D016063:Blood Loss, Surgical; D058731:Blood Safety / Q000295:instrumentation / Q000379:methods*; D017558:Elective Surgical Procedures; D017707:Erythrocyte Transfusion / Q000009:adverse effects / Q000379:methods*; D005260:Female; D005374:Filtration; D006801:Humans; D007114:Immunization; D007518:Isoantibodies / Q000096:biosynthesis / Q000097:blood; D008297:Male; D008875:Middle Aged; D017096:Prion Diseases / Q000517:prevention & control* / Q000635:transmission; D011328:Prions; D012117:Resins, Synthetic; D016060:Sorption Detoxification / Q000295:instrumentation / Q000379:methods*
chemical_list: D001789:Blood Group Antigens; D007518:Isoantibodies; D011328:Prions; D012117:Resins, Synthetic