Effect of Product Related Factors on Platelet Concentrate Transfusion Response in Patients With Hematologic Malignacies (TCP)

September 29, 2017 updated by: Etablissement Français du Sang

Analyse de l'Effet Des caractéristiques de concentrés Plaquettaires Sur le Rendement Transfusionnel Chez Les Patients Ayant Une hémopathie Maligne et bénéficiant de Transfusions Plaquettaires à Titre Prophylactique

Platelet concentrates (PCs) characteristics, such as storage duration, ABO compatibility, dose and source, may have an impact on transfusion responses and outcomes. Because of the relative scarcity of PCs the selection of a specific PC for issue to the patient remains a challenging process. Regulatory agencies do not fully address these characteristics in their recommendations for prophylactic transfusions.

The aim of the study was to analyse the effect of product-related factors in a real life setting, in order to determine which ones are the most relevant when selecting PCs for patients in prophylactic conditions. Two different endpoints are studied: the corrected count increment and the platelet transfusion time intervals.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Other: Platelet concentrate transfusion

Study Type

Observational

Enrollment (Actual)

1101

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All patients with hematologic malignancies treated at the university hospital of Besançon who received at least one prophylactic platelet transfusion

Description

Inclusion Criteria:

Inpatients in the hematology department between January 2001 and December 2012
Hematologic malignancy
At least one platelet transfusion (with platelet count ≤ 25 G/L)
Age 18 and over at time of first transfusion

Exclusion Criteria:

More than one hematologic malignancy
Non-malignant haematological disorder

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Corrected count increment Time Frame: 24 hours post transfusion	Platelet increment corrected for platelet dose and body surface area	24 hours post transfusion

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Transfusion interval Time Frame: 7 days	Time interval to following platelet transfusion in days	7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Etablissement Français du Sang

Collaborators

Centre Hospitalier Universitaire de Besancon

Investigators

Principal Investigator: Laurent BARDIAUX, MD, Etablissement francais du sang

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2015

Primary Completion (Actual)

March 1, 2016

Study Completion (Actual)

March 1, 2016

Study Registration Dates

First Submitted

August 26, 2016

First Submitted That Met QC Criteria