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Italian Platelet Technology Assessment Study

NCT01642563 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 456

Last updated 2015-07-28

No results posted yet for this study

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

Interventions

PROCEDURE

Platelet transfusion

One dose of pathogen reduced platelets

PROCEDURE

Platelet transfusion

One dose of standard platelets

Sponsors & Collaborators

  • Cerus Corporation

    collaborator INDUSTRY

  • Terumo BCT

    collaborator INDUSTRY

  • Centro Nazionale Sangue

    lead OTHER_GOV

Principal Investigators

  • Paolo Rebulla, MD · Fondazione Ca' Granda Ospedale Maggiore Policlinico

  • Stefania Frasca, Eng · Data Management

  • Laura Angelici, MD · Fondazione Ca' Granda ospedale Maggiore Policlinico

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-10-31
Primary Completion
2014-10-31
Completion
2015-03-31

Countries

  • Italy

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01642563 on ClinicalTrials.gov