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

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.

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Key information

Conditions

Lymphoma Blood Protein Disorders Cardiovascular Diseases Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Hodgkin Disease Immune System Diseases Immunoproliferative Disorders Leukemia Leukemia, Lymphoid Lymphatic Diseases Lymphocytic Leukemia Lymphoproliferative Disorders Multiple Myeloma Neoplasms Neoplasms by Histologic Type Neoplasms, Plasma Cell Paraproteinemias Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Platelet concentrate transfusion

Other

Primary outcomes

Corrected count increment

Time frame: 24 hours post transfusion

Platelet increment corrected for platelet dose and body surface area

Secondary outcomes

Transfusion interval

Time frame: 7 days

Time interval to following platelet transfusion in days

Sponsors and collaborators

Lead sponsor

Etablissement Français du Sang

Other

Collaborators

Centre Hospitalier Universitaire de Besancon

Registry information

Official study title

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

Acronym: TCP

Important dates

Study start: 2015
Primary completion: 2016
Study completion: 2016
First posted: Aug 31, 2016
Registry last updated: Oct 2, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed