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

Sponsor
Etablissement Français du Sang (Other)
Overall Status
Completed
CT.gov ID
NCT02885038
Collaborator
Centre Hospitalier Universitaire de Besancon (Other)
1,101
Enrollment
14
Duration (Months)

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Other: Platelet concentrate transfusion

Study Design

Study Type:
Observational
Actual Enrollment :
1101 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
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
Study Start Date :
Jan 1, 2015
Actual Primary Completion Date :
Mar 1, 2016
Actual Study Completion Date :
Mar 1, 2016

Outcome Measures

Primary Outcome Measures

  1. Corrected count increment [24 hours post transfusion]

    Platelet increment corrected for platelet dose and body surface area

Secondary Outcome Measures

  1. Transfusion interval [7 days]

    Time interval to following platelet transfusion in days

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Etablissement Français du Sang
  • Centre Hospitalier Universitaire de Besancon

Investigators

  • Principal Investigator: Laurent BARDIAUX, MD, Etablissement Français du Sang

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Etablissement Français du Sang
ClinicalTrials.gov Identifier:
NCT02885038
Other Study ID Numbers:
  • CPP14/05
  • DR-2015-392
First Posted:
Aug 31, 2016
Last Update Posted:
Oct 2, 2017
Last Verified:
Sep 1, 2016
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Keywords provided by Etablissement Français du Sang
Platelet Transfusion
Additional relevant MeSH terms:
Multiple Myeloma
Hodgkin Disease

Study Results

No Results Posted as of Oct 2, 2017