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NCT02885038 Clinical Trial

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

Multiple Myeloma Clinical Trial

— TCP  

Official 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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02885038
Other study ID # CPP14/05
Secondary ID DR-2015-392
Status Completed
Phase N/A
First received August 26, 2016
Last updated September 29, 2017
Start date January 2015
Est. completion date March 2016

Study information
Verified date September 2016
Source Etablissement Français du Sang
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 1101
Est. completion date March 2016
Est. primary completion date March 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Other:
• Platelet concentrate transfusion

Locations
Country Name City State
n/a

Sponsors (2)
Lead Sponsor Collaborator
Etablissement Français du Sang Centre Hospitalier Universitaire de Besancon

Outcome
Type Measure Description Time frame Safety issue
Primary Corrected count increment Platelet increment corrected for platelet dose and body surface area 24 hours post transfusion
Secondary Transfusion interval Time interval to following platelet transfusion in days 7 days
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