Italian Platelet Technology Assessment Study

Phase 3

Terminated

• Conditions: Leukemia; Lymphoma
• Interventions: Procedure: Platelet transfusion

• Registration Number: NCT01642563
• Lead Sponsor: Centro Nazionale Sangue

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.

Study Timeline

• Study Start: 2010-10
• Study First Submitted: 2012-07-13
• Study First Submitted QC: 2012-07-16
• Study First Posted: 2012-07-17
• Status Verified: 2014-09
• Primary Completion: 2014-10
• Study Completion: 2015-03
• Last Update Submitted: 2015-07-27
• Last Update Posted: 2015-07-28

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 456

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard platelets	Platelet transfusion	Transfusion
Pathogen reduced platelets	Platelet transfusion	Transfusion

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Number of days with grade 2 or greater bleeding during the period of platelet transfusion support	Within 4 weeks after randomization
Post-transfusion platelet count increments	Within 4 weeks after randomization
Proportion of patients with acute transfusion reactions	Within 4 weeks after randomization
Total dose of platelets transfused per day of thrombocytopenic platelet support	Within 4 weeks after randomization
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 platelet units transfused per day of thrombocytopenic platelet support	Within 4 weeks after randomization

Trial Locations

Locations (9)

Azienda Ospedaliera Universitaria San Martino; 🇮🇹 Genova, Italy

Fondazione Ca' Granda Ospedale Maggiore Policlinico; 🇮🇹 Milano, Italy

Ospedale di Udine; 🇮🇹 Udine, Italy

Azienda Ospedaliera Universitaria Federico II; 🇮🇹 Napoli, Italy

Fondazione IRCCS Policlinico San Matteo; 🇮🇹 Pavia, Italy

Azienda Ospedaliera Policlinico Umberto I; 🇮🇹 Roma, Italy

Ospedale di Padova; 🇮🇹 Padova, Italy

Azienda Ospedaliera Verona; 🇮🇹 Verona, Italy

Proteomics Laboratory, Università della Tuscia; 🇮🇹 Viterbo, Italy