Italian Platelet Technology Assessment Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

456 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-10-31

Study Completion Date

2015-03-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Leukemia Lymphoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Pathogen reduced platelets

Transfusion

Group Type EXPERIMENTAL

Platelet transfusion

Intervention Type PROCEDURE

One dose of pathogen reduced platelets

Standard platelets

Transfusion

Group Type ACTIVE_COMPARATOR

Platelet transfusion

Intervention Type PROCEDURE

One dose of standard platelets

Interventions

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Platelet transfusion

One dose of pathogen reduced platelets

Intervention Type PROCEDURE

Platelet transfusion

One dose of standard platelets

Intervention Type PROCEDURE

Other Intervention Names

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Intercept Mirasol

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No