Italian Platelet Technology Assessment Study (IPTAS)

• Time to the first grade 2 or greater bleeding event after the first study transfusion [ Time Frame: Within 4 weeks after randomization ] [ Designated as safety issue: No ]
• Proportion of transfusions given to treat breakthrough bleeding [ Time Frame: Within 4 weeks after randomization ] [ Designated as safety issue: No ]
• Number of days with grade 2 or greater bleeding during the period of platelet transfusion support [ Time Frame: Within 4 weeks after randomization ] [ Designated as safety issue: No ]
• Number of platelet units transfused per day of thrombocytopenic platelet support [ Time Frame: Within 4 weeks after randomization ] [ Designated as safety issue: No ]
• Proportion of patients with acute transfusion reactions [ Time Frame: Within 4 weeks after randomization ] [ Designated as safety issue: No ]
• Post-transfusion platelet count increments [ Time Frame: Within 4 weeks after randomization ] [ Designated as safety issue: No ]
• Total dose of platelets transfused per day of thrombocytopenic platelet support [ Time Frame: Within 4 weeks after randomization ] [ Designated as safety issue: No ]

Italian Platelet Technology Assessment Study (IPTAS) aims at comparing bleeding frequency and severity after transfusion of standard platelets versus platelets prepared with two commercial pathogen reduction technologies (PRT) and to perform a proteomic analysis of standard versus PRT platelets. The two technologies will be analyzed separately.

Primary endpoint: incidence of bleeding of grade 2 or greater in recipients of PRT platelets versus incidence in recipients of control (standard) platelets.

Secondary endpoints: time to the first grade 2 or greater bleeding event after the first study transfusion; proportion of transfusions given to treat breakthrough bleeding; number of days with grade 2 or greater bleeding during the period of platelet transfusion support; number of platelet units transfused and total dose of platelets transfused per day of thrombocytopenic platelet support; proportion of patients with acute transfusion reactions; post-transfusion platelet count increments

Observational endpoints: frequency of human leukocyte antigen (HLA) alloimmunization, frequency of clinical refractoriness to platelet transfusion with demonstrated HLA alloimmunization, frequency of clinical refractoriness to platelet transfusion that is persistent during the period of platelet support in the absence of HLA or human platelet antigen (HPA) alloimmunization

Patients will be evaluated for 4 weeks after randomization.

When patient's platelet count, done in early morning every day, falls below 10000/microliter, physician in charge issues a platelet transfusion request to transfusion service. Transfusion service (which knows patient treatment arm) issues a PRT product or a standard product as indicated, typically within hours of request receipt; patient's physician identifies unit code and intended recipient's code and determines vital signs (pulse, blood pressure, body temp). Transfusion is started and completed in 30 min. Adverse reactions are monitored by ward personnel and once a day IPTAS local coordinator visits the ward, checks IPTAS patients' records, fills IPTAS forms, examines and interviews each enrolled patient and transfers filled forms to data coordinating center in Milan.

• Leukemia
• Lymphoma

• Procedure: Platelet transfusion
  One dose of pathogen reduced platelets
  Other Names:

  • Intercept
  • Mirasol
• Procedure: Platelet transfusion
  One dose of standard platelets

• Experimental: Pathogen reduced platelets
  Transfusion
  Intervention: Procedure: Platelet transfusion
• Active Comparator: Standard platelets
  Transfusion
  Intervention: Procedure: Platelet transfusion

Inclusion Criteria:

1. adults (> 18 years)
2. a hematooncology diagnosis (includes patients newly diagnosed and previously diagnosed)
3. expected to require 2 or more PLT transfusions in 4 weeks
4. hospital admission (patients admitted to out-patient clinics will not be enrolled)
5. chemotherapy, related and matched unrelated donor (MUD)transplant recipients
6. recurrent auto-transplanted patients, requiring chemotherapy
7. negative pregnancy test in female patients less than 60 years old

Exclusion Criteria:

1. presence of HLA class I abs on admission with PRA >20%
2. historical documented record of 2 or more 1 hour post-TX PLT corrected count increments <5,000 per microliter
3. previously included in IPTAS
4. diagnosis of a solid tumor

• Cerus Corporation
• Terumo BCT