Italian Platelet Technology Assessment Study (IPTAS)
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Leukemia Lymphoma |
Procedure: Platelet transfusion |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Supportive Care |
| 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 |
- 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 ] [ Designated as safety issue: Yes ]
- Time to the first grade 2 or greater bleeding event after the first study transfusion [ Time Frame: Within 4 weeks after randomization ] [ Designated as safety issue: No ]
- Proportion of transfusions given to treat breakthrough bleeding [ Time Frame: Within 4 weeks after randomization ] [ Designated as safety issue: No ]
- Number of days with grade 2 or greater bleeding during the period of platelet transfusion support [ Time Frame: Within 4 weeks after randomization ] [ Designated as safety issue: No ]
- Number of platelet units transfused per day of thrombocytopenic platelet support [ Time Frame: Within 4 weeks after randomization ] [ Designated as safety issue: No ]
- Proportion of patients with acute transfusion reactions [ Time Frame: Within 4 weeks after randomization ] [ Designated as safety issue: No ]
- Post-transfusion platelet count increments [ Time Frame: Within 4 weeks after randomization ] [ Designated as safety issue: No ]
- Total dose of platelets transfused per day of thrombocytopenic platelet support [ Time Frame: Within 4 weeks after randomization ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 828 |
| Study Start Date: | October 2010 |
| Estimated Study Completion Date: | August 2014 |
| Estimated Primary Completion Date: | August 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Pathogen reduced platelets
Transfusion
|
Procedure: Platelet transfusion
One dose of pathogen reduced platelets
Other Names:
|
|
Active Comparator: Standard platelets
Transfusion
|
Procedure: Platelet transfusion
One dose of standard platelets
|
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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| Contact: Stefania Vaglio, MD | +39-06-4990-4987 | ricerca.cns@iss.it |
| Contact: Valentina Panetta, MD | cns@iss.it |
| Italy | |
| Azienda Ospedaliera Universitaria San Martino | Recruiting |
| Genova, Italy | |
| Contact: Paolo Strada, MD paolo.strada@hsanmartino.it | |
| Principal Investigator: Paolo Strada, MD | |
| Sub-Investigator: Francesco Bek, DSc | |
| Fondazione Ca' Granda Ospedale Maggiore Policlinico | Recruiting |
| Milano, Italy | |
| Contact: Maurizio Marconi, MD mmarconi@policlinico.mi.it | |
| Principal Investigator: Maurizio Marconi, MD | |
| Sub-Investigator: Barbara Olivero, MD | |
| Sub-Investigator: Noemi Greppi, DSc | |
| Azienda Ospedaliera Universitaria Federico II | Recruiting |
| Napoli, Italy | |
| Contact: Nicola Scarpato, MD | |
| Contact scarpato@unina.it | |
| Principal Investigator: Nicola Scarpato, MD | |
| Sub-Investigator: Maria Rosaria De Pascale, MD | |
| Sub-Investigator: Giorgio Fratellanza, MD | |
| Ospedale di Padova | Not yet recruiting |
| Padova, Italy | |
| Contact: Giustina De Silvestro, MD +39-049-8212841 giustina.desilvestro@sanita.padova.it | |
| Principal Investigator: Giustina De Silvestro, MD | |
| Fondazione IRCCS Policlinico San Matteo | Recruiting |
| Pavia, Italy | |
| Contact: Laura Salvaneschi, MD l.salvaneschi@smatteo.pv.it | |
| Principal Investigator: Laura Salvaneschi, MD | |
| Sub-Investigator: Roberta Monti, DSc | |
| Azienda Ospedaliera Policlinico Umberto I | Recruiting |
| Roma, Italy | |
| Contact: Gabriella Girelli, MD girelli@bce.uniroma1.it | |
| Principal Investigator: Gabriella Girelli, MD | |
| Sub-Investigator: Serelina Coluzzi, MD | |
| Ospedale di Udine | Not yet recruiting |
| Udine, Italy | |
| Contact: Vincenzo De Angelis, MD +39-0432-552340 deangelis.vincenzo@aoud.sanita.fvg.it | |
| Sub-Investigator: Cristina Melli, MD | |
| Principal Investigator: Vincenzo De Angelis, MD | |
| Azienda Ospedaliera Verona | Recruiting |
| Verona, Italy | |
| Contact: Giuseppe Aprili, MD giuseppe.aprili@azosp.vr.it | |
| Principal Investigator: Giuseppe Aprili, MD | |
| Sub-Investigator: Giorgio Gandini, MD | |
| Sub-Investigator: Marianna Rinaldi, DSc | |
| Proteomics Laboratory, Università della Tuscia | Not yet recruiting |
| Viterbo, Italy | |
| Contact: Lello Zolla, MD zolla@unitus.it | |
| Principal Investigator: Lello Zolla, MD | |
| Sub-Investigator: Alessandro D'Angelo, MD | |
| 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 |
More Information
No publications provided
| Responsible Party: | Centro Nazionale Sangue |
| ClinicalTrials.gov Identifier: | NCT01642563 History of Changes |
| Other Study ID Numbers: | ISS-2007646931 |
| Study First Received: | July 13, 2012 |
| Last Updated: | February 15, 2013 |
| Health Authority: | Italy: Ministry of Health |
Keywords provided by Centro Nazionale Sangue:
|
Platelet transfusion Leukemia Transfusion transmissible infections Chemotherapy Allogeneic hemopoietic stem cell transplant |
Additional relevant MeSH terms:
|
Leukemia Lymphoma Neoplasms by Histologic Type Neoplasms |
Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases |
ClinicalTrials.gov processed this record on June 17, 2013