- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01642563
Italian Platelet Technology Assessment Study (IPTAS)
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
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
-
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
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
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
|
One dose of pathogen reduced platelets
Other Names:
One dose of standard platelets
|
Active Comparator: Standard platelets
Transfusion
|
One dose of pathogen reduced platelets
Other Names:
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
Sponsor
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
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
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
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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