Italian Platelet Technology Assessment Study

NCT01642563 | Terminated Phase 3 DMC

• 1 other identifier: ISS-2007646931
• Study Type: interventional
• Target: 456
• Locations: 1 country
• Sites: 9

Brief Summary

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.

Conditions

Leukemia; Lymphoma

Keywords

Platelet transfusion; Leukemia; Transfusion transmissible infections; Chemotherapy; Allogeneic hemopoietic stem cell transplant

Outcome Measures

Primary Outcomes (1)

• Incidence of bleeding of grade 2 or greater in recipients of PRT platelets versus incidence in recipients of control (standard) platelets

  Within 4 weeks after randomization

Secondary Outcomes (7)

• Time to the first grade 2 or greater bleeding event after the first study transfusion

  Within 4 weeks after randomization

• Proportion of transfusions given to treat breakthrough bleeding

  Within 4 weeks after randomization

• Number of days with grade 2 or greater bleeding during the period of platelet transfusion support

  Within 4 weeks after randomization

• Number of platelet units transfused per day of thrombocytopenic platelet support

  Within 4 weeks after randomization

• Proportion of patients with acute transfusion reactions

  Within 4 weeks after randomization

Study Arms (2)

Pathogen reduced platelets

EXPERIMENTAL

Transfusion

Procedure: Platelet transfusion

Standard platelets

ACTIVE COMPARATOR

Transfusion

Procedure: Platelet transfusion

Interventions

Platelet transfusion PROCEDURE

One dose of pathogen reduced platelets

Also known as: Intercept, Mirasol

Pathogen reduced platelets

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centro Nazionale Sangue: lead
• Cerus Corporation: collaborator
• Terumo BCT: collaborator

Study Sites (9)

Azienda Ospedaliera Universitaria San Martino

Genova, Italy

Location

Fondazione Ca' Granda Ospedale Maggiore Policlinico

Milan, Italy

Location

Azienda Ospedaliera Universitaria Federico II

Napoli, Italy

Location

Ospedale di Padova

Padua, Italy

Location

Fondazione IRCCS Policlinico San Matteo

Pavia, Italy

Location

Azienda Ospedaliera Policlinico Umberto I

Roma, Italy

Location

Ospedale di Udine

Udine, Italy

Location

Azienda Ospedaliera Verona

Verona, Italy

Location

Proteomics Laboratory, Università della Tuscia

Viterbo, Italy

Location

Related Publications (1)

• 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.

  BACKGROUND

MeSH Terms

Conditions

Leukemia; Lymphoma

Interventions

Platelet Transfusion

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Blood Component Transfusion; Blood Transfusion; Biological Therapy; Therapeutics

Study Officials

• Paolo Rebulla, MD

  Fondazione Ca' Granda Ospedale Maggiore Policlinico

  PRINCIPAL INVESTIGATOR

• Stefania Frasca, Eng

  Data Management

  STUDY DIRECTOR

• Laura Angelici, MD

  Fondazione Ca' Granda ospedale Maggiore Policlinico

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 13, 2012
• First Posted: July 17, 2012
• Study Start: October 1, 2010
• Primary Completion: October 1, 2014
• Study Completion: March 1, 2015
• Last Updated: July 28, 2015

Record last verified: 2014-09

Locations

IT (9)