Italian Platelet Technology Assessment Study

Lymphoma Clinical Trial

— IPTAS  

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01642563
• Other study ID #: ISS-2007646931
• Status: Terminated
• Phase: Phase 3
• First received: July 13, 2012
• Last updated: July 27, 2015
• Start date: October 2010
• Est. completion date: March 2015

Study information

• Verified date: September 2014
• Source: Centro Nazionale Sangue
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 456
• Est. completion date: March 2015
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Leukemia
• Lymphoma

Intervention

Procedure:
• Platelet transfusion
One dose of pathogen reduced platelets
• Platelet transfusion
One dose of standard platelets

Locations

Country	Name	City	State
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

Sponsors (3)

Lead Sponsor	Collaborator
Centro Nazionale Sangue	Cerus Corporation, Terumo BCT

Country where clinical trial is conducted

Italy, 

References & 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.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	Time to the first grade 2 or greater bleeding event after the first study transfusion		Within 4 weeks after randomization	No
Secondary	Proportion of transfusions given to treat breakthrough bleeding		Within 4 weeks after randomization	No
Secondary	Number of days with grade 2 or greater bleeding during the period of platelet transfusion support		Within 4 weeks after randomization	No
Secondary	Number of platelet units transfused per day of thrombocytopenic platelet support		Within 4 weeks after randomization	No
Secondary	Proportion of patients with acute transfusion reactions		Within 4 weeks after randomization	No
Secondary	Post-transfusion platelet count increments		Within 4 weeks after randomization	No
Secondary	Total dose of platelets transfused per day of thrombocytopenic platelet support		Within 4 weeks after randomization	No