Italian Platelet Technology Assessment Study (IPTAS)

July 27, 2015 updated by: Centro Nazionale Sangue

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

456

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Genova, Italy
        • Azienda Ospedaliera Universitaria San Martino
      • Milano, Italy
        • Fondazione Ca' Granda Ospedale Maggiore Policlinico
      • Napoli, Italy
        • Azienda Ospedaliera Universitaria Federico II
      • Padova, Italy
        • Ospedale di Padova
      • Pavia, Italy
        • Fondazione IRCCS Policlinico San Matteo
      • Roma, Italy
        • Azienda Ospedaliera Policlinico Umberto I
      • Udine, Italy
        • Ospedale di Udine
      • Verona, Italy
        • Azienda Ospedaliera Verona
      • Viterbo, Italy
        • Proteomics Laboratory, Università della Tuscia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Pathogen reduced platelets
Transfusion
Procedure: Platelet transfusion
One dose of pathogen reduced platelets
Other Names:
  • Intercept
  • Mirasol
Procedure: Platelet transfusion
One dose of standard platelets
Active Comparator: Standard platelets
Transfusion
Procedure: Platelet transfusion
One dose of pathogen reduced platelets
Other Names:
  • Intercept
  • Mirasol
Procedure: Platelet transfusion
One dose of standard platelets

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centro Nazionale Sangue

Collaborators

Terumo BCT
Cerus Corporation

Investigators

  • Principal Investigator: Paolo Rebulla, MD, Fondazione Ca' Granda Ospedale Maggiore Policlinico
  • Study Director: Stefania Frasca, Eng, Data Management
  • Study Director: Laura Angelici, MD, Fondazione Ca' Granda Ospedale Maggiore Policlinico

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

  • 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.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2010

Primary Completion (Actual)

October 1, 2014

Study Completion (Actual)

March 1, 2015

Study Registration Dates

First Submitted

July 13, 2012

First Submitted That Met QC Criteria

July 16, 2012

First Posted (Estimate)

July 17, 2012

Study Record Updates

Last Update Posted (Estimate)

July 28, 2015

Last Update Submitted That Met QC Criteria

July 27, 2015

Last Verified

September 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ISS-2007646931

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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