Clinical trial NCT01642563: Italian Platelet Technology Assessment Study
Official title: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Leukemia
Lymphoma
Keywords: Platelet transfusion
Leukemia
Transfusion transmissible infections
Chemotherapy
Allogeneic hemopoietic stem cell transplant
Lead sponsor: Centro Nazionale Sangue
Sponsor class: OTHER_GOV
Collaborators: name: Cerus Corporation
name: Terumo BCT
First posted: 2012-07-17
Enrollment: 456
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Incidence of bleeding of grade 2 or greater in recipients of PRT platelets versus incidence in recipients of control (standard) platelets
timeFrame: Within 4 weeks after randomization
Secondary outcomes:
measure: Time to the first grade 2 or greater bleeding event after the first study transfusion
timeFrame: Within 4 weeks after randomization
measure: Proportion of transfusions given to treat breakthrough bleeding
timeFrame: Within 4 weeks after randomization
measure: Number of days with grade 2 or greater bleeding during the period of platelet transfusion support
timeFrame: Within 4 weeks after randomization
measure: Number of platelet units transfused per day of thrombocytopenic platelet support
timeFrame: Within 4 weeks after randomization
measure: Proportion of patients with acute transfusion reactions
timeFrame: Within 4 weeks after randomization
measure: Post-transfusion platelet count increments
timeFrame: Within 4 weeks after randomization
measure: Total dose of platelets transfused per day of thrombocytopenic platelet support
timeFrame: Within 4 weeks after randomization
Other outcomes:
Locations:
city: Genova
country: Italy
facility: Azienda Ospedaliera Universitaria San Martino
city: Milano
country: Italy
facility: Fondazione Ca' Granda Ospedale Maggiore Policlinico
city: Napoli
country: Italy
facility: Azienda Ospedaliera Universitaria Federico II
city: Padova
country: Italy
facility: Ospedale di Padova
city: Pavia
country: Italy
facility: Fondazione IRCCS Policlinico San Matteo
city: Roma
country: Italy
facility: Azienda Ospedaliera Policlinico Umberto I
city: Udine
country: Italy
facility: Ospedale di Udine
city: Verona
country: Italy
facility: Azienda Ospedaliera Verona
city: Viterbo
country: Italy
facility: Proteomics Laboratory, Università della Tuscia
Study officials:
affiliation: Fondazione Ca' Granda Ospedale Maggiore Policlinico
name: Paolo Rebulla, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Data Management
name: Stefania Frasca, Eng
role: STUDY_DIRECTOR
affiliation: Fondazione Ca' Granda ospedale Maggiore Policlinico
name: Laura Angelici, MD
role: STUDY_DIRECTOR
References:
citation: Rebulla P, Grazzini G, Liumbruno GM, Aprili G, Formisano S, Girelli G, Marconi M, Salvaneschi L, Strada P, Zolla L. Pathogen inactivated platelets and prevention of immunological adverse reactions: the Italian Platelet Technology Assessment Study (IPTAS). Blood Transfus 2009;7 Suppl 1:s19-s21. DOI 10.2450/2009.0013-09.