- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02885038
Effect of Product Related Factors on Platelet Concentrate Transfusion Response in Patients With Hematologic Malignacies (TCP)
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
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.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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 Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Corrected count increment
Time Frame: 24 hours post transfusion
|
Platelet increment corrected for platelet dose and body surface area
|
24 hours post transfusion
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Transfusion interval
Time Frame: 7 days
|
Time interval to following platelet transfusion in days
|
7 days
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Laurent BARDIAUX, MD, Etablissement francais du sang
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Lymphatic Diseases
- Immunoproliferative Disorders
- Hematologic Diseases
- Hemorrhagic Disorders
- Hemostatic Disorders
- Paraproteinemias
- Blood Protein Disorders
- Neoplasms, Plasma Cell
- Lymphoma
- Multiple Myeloma
- Hodgkin Disease
Other Study ID Numbers
- CPP14/05
- DR-2015-392 (Other Identifier: French Data Protection Authority)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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