Italian Platelet Technology Assessment Study

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Multi-center, Single-blind, Randomized, Parallel, Non Inferiority Study to Separately Investigate the Effect of Standard Platelets Versus Platelets Prepared With Two Commercial Procedures of Pathogen Reduction Technologies (PRT) on Bleeding Incidence and Severity in Thrombocytopenic Recipients

Conditions
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Lymphoma, Leukemia

Intervention / Treatment
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* Procedure: Platelet transfusion
* Procedure: Platelet transfusion


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: adults (> 18 years) a hematooncology diagnosis (includes patients newly diagnosed and previously diagnosed) expected to require 2 or more PLT transfusions in 4 weeks hospital admission (patients admitted to out-patient clinics will not be enrolled) chemotherapy, related and matched unrelated donor (MUD)transplant recipients recurrent auto-transplanted patients, requiring chemotherapy negative pregnancy test in female patients less than 60 years old Exclusion Criteria: presence of HLA class I abs on admission with PRA >20% historical documented record of 2 or more 1 hour post-TX PLT corrected count increments <5,000 per microliter previously included in IPTAS diagnosis of a solid tumor

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pathogen reduced platelets<br>Transfusion | Procedure: Platelet transfusion<br>* One dose of pathogen reduced platelets<br>* Other names: Mirasol;|
| Active Comparator: Standard platelets<br>Transfusion | Procedure: Platelet transfusion<br>* One dose of standard platelets<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of bleeding of grade 2 or greater in recipients of PRT platelets versus incidence in recipients of control (standard) platelets |  | Within 4 weeks after randomization | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to the first grade 2 or greater bleeding event after the first study transfusion |  | Within 4 weeks after randomization | 
| Proportion of transfusions given to treat breakthrough bleeding |  | Within 4 weeks after randomization | 
| Number of days with grade 2 or greater bleeding during the period of platelet transfusion support |  | Within 4 weeks after randomization | 
| Number of platelet units transfused per day of thrombocytopenic platelet support |  | Within 4 weeks after randomization | 
| Proportion of patients with acute transfusion reactions |  | Within 4 weeks after randomization | 
| Post-transfusion platelet count increments |  | Within 4 weeks after randomization | 
| Total dose of platelets transfused per day of thrombocytopenic platelet support |  | Within 4 weeks after randomization | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Platelet transfusion, Leukemia, Transfusion transmissible infections, Chemotherapy, Allogeneic hemopoietic stem cell transplant