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

NCT ID: NCT02885038

Last Updated: 2017-10-02

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

COMPLETED

Total Enrollment

1101 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-01-31

Study Completion Date

2016-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Lymphoma Multiple Myeloma Lymphocytic Leukemia Hodgkin Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Interventions

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Platelet concentrate transfusion

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire de Besancon

OTHER

Sponsor Role collaborator

Etablissement Français du Sang

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Laurent BARDIAUX, MD

Role: PRINCIPAL_INVESTIGATOR

Etablissement Français du Sang

Other Identifiers

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DR-2015-392

Identifier Type: OTHER

Identifier Source: secondary_id

CPP14/05

Identifier Type: -

Identifier Source: org_study_id