NCT02885038

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,101

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2015

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

August 26, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 31, 2016

Completed
Last Updated

October 2, 2017

Status Verified

September 1, 2016

Enrollment Period

1.2 years

First QC Date

August 26, 2016

Last Update Submit

September 29, 2017

Conditions

LymphomaMultiple MyelomaLymphocytic LeukemiaHodgkin Disease

Keywords

Platelet Transfusion

Outcome Measures

Primary Outcomes (1)

  • Corrected count increment

    Platelet increment corrected for platelet dose and body surface area

    24 hours post transfusion

Secondary Outcomes (1)

  • Transfusion interval

    7 days

Interventions

Platelet concentrate transfusionOTHER

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • More than one hematologic malignancy
  • Non-malignant haematological disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

LymphomaMultiple MyelomaLeukemia, LymphoidHodgkin Disease

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesNeoplasms, Plasma CellHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHematologic DiseasesHemorrhagic DisordersLeukemia

Study Officials

  • Laurent BARDIAUX, MD

    Etablissement Français du Sang

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 26, 2016

First Posted

August 31, 2016

Study Start

January 1, 2015

Primary Completion

March 1, 2016

Study Completion

March 1, 2016

Last Updated

October 2, 2017

Record last verified: 2016-09