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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

July 13, 2012
September 23, 2014
October 2010
September 2014   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01642563 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Italian Platelet Technology Assessment Study
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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Supportive Care
  • Leukemia
  • Lymphoma
  • Procedure: Platelet transfusion
    One dose of pathogen reduced platelets
    Other Names:
    • Intercept
    • Mirasol
  • Procedure: Platelet transfusion
    One dose of standard platelets
  • Experimental: Pathogen reduced platelets
    Transfusion
    Intervention: Procedure: Platelet transfusion
  • Active Comparator: Standard platelets
    Transfusion
    Intervention: Procedure: Platelet transfusion
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
456
September 2014
September 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Italy
 
NCT01642563
ISS-2007646931
Yes
Centro Nazionale Sangue
Centro Nazionale Sangue
  • Cerus Corporation
  • Terumo BCT
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
Centro Nazionale Sangue
September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP