Italian Platelet Technology Assessment Study (IPTAS)

This study has been terminated.
(Patient enrolment below planned schedule)
Sponsor:
Collaborators:
Cerus Corporation
Terumo BCT
Information provided by (Responsible Party):
Centro Nazionale Sangue
ClinicalTrials.gov Identifier:
NCT01642563
First received: July 13, 2012
Last updated: September 23, 2014
Last verified: September 2014
  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

Resource links provided by NLM:


Further study details as provided by Centro Nazionale Sangue:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 456
Study Start Date: October 2010
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: September 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:
  • Intercept
  • Mirasol
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
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01642563

Locations
Italy
Azienda Ospedaliera Universitaria San Martino
Genova, Italy
Fondazione Ca' Granda Ospedale Maggiore Policlinico
Milano, Italy
Azienda Ospedaliera Universitaria Federico II
Napoli, Italy
Ospedale di Padova
Padova, Italy
Fondazione IRCCS Policlinico San Matteo
Pavia, Italy
Azienda Ospedaliera Policlinico Umberto I
Roma, Italy
Ospedale di Udine
Udine, Italy
Azienda Ospedaliera Verona
Verona, Italy
Proteomics Laboratory, Università della Tuscia
Viterbo, Italy
Sponsors and Collaborators
Centro Nazionale Sangue
Cerus Corporation
Terumo BCT
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
  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: September 23, 2014
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
Neoplasms by Histologic Type
Neoplasms

ClinicalTrials.gov processed this record on October 16, 2014