LymphomaTCPNCT02885038
Effect of Product Related Factors on Platelet Concentrate Transfusion Response in Patients With Hematologic Malignacies
An observational study of Lymphoma and Multiple Myeloma, run by Etablissement Français du Sang.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lymphoma, Multiple Myeloma, Lymphocytic Leukemia
- What is being tested?
- Platelet concentrate transfusion
- How many people
- 1,101 participants
- Where
- No sites listed yet
- Study dates
- Jan 2015to Mar 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients with hematologic malignancies treated at the university hospital of Besançon who received at least one prophylactic platelet transfusion
Who may be able to join
- 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
Who cannot join
- More than one hematologic malignancy
- Non-malignant haematological disorder
About this study
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
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.
- Conditions
- Lymphoma, Multiple Myeloma, Lymphocytic Leukemia, Hodgkin Disease
- Being tested
- Platelet concentrate transfusion
- Keywords
- Platelet Transfusion
- Medical subject headings
- Lymphoma, Multiple Myeloma, Leukemia, Lymphoid, Hodgkin Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Platelet concentrate transfusionOther
What is being measured
The primary outcome is the main question the study is designed to answer.
Corrected count increment
Platelet increment corrected for platelet dose and body surface area
Measured: 24 hours post transfusion
Secondary outcomes (1)
Transfusion interval
Time interval to following platelet transfusion in days
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2016 (estimated)
- Study startJan 2015
- Primary completionMar 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LymphomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,101 participants (actual)
Sponsor and investigators
- Lead sponsor
- Etablissement Français du Sang
- Sponsor type
- University, hospital or other
- Collaborators
- Centre Hospitalier Universitaire de Besancon
- Responsible party
- Sponsor
- Investigators
- Laurent BARDIAUX, MD, Principal investigator, Etablissement Français du Sang
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02885038
- Sponsor's protocol ID
- CPP14/05
- Other IDs
- DR-2015-392
- Acronym
- TCP
- Status last verified
- Sep 2016
- First submitted
- 26 Aug 2016
- Last updated
- 2 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02885038
- Acronym / sponsor ID
- TCP / CPP14/05
- Conditions
- Lymphoma, Multiple Myeloma, Lymphocytic Leukemia, Hodgkin Disease
- Keywords
- Platelet Transfusion
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,101 participants (actual)
- Lead sponsor
- Etablissement Français du SangUniversity, hospital or other
- Collaborators
- Centre Hospitalier Universitaire de Besancon
- Study start
- Jan 2015
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 31 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients with hematologic malignancies treated at the university hospital of Besançon who received at least one prophylactic platelet transfusion
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- More than one hematologic malignancy
- Non-malignant haematological disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Platelet concentrate transfusion | Other | – |
Primary outcome
Corrected count increment
Time frame: 24 hours post transfusion
Platelet increment corrected for platelet dose and body surface area
1 secondary outcome
Transfusion interval
Time frame: 7 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2017.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laurent BARDIAUX, MD principal investigator
Etablissement Français du Sang
Questions about this trial
What is this clinical trial studying?
An observational study of Lymphoma and Multiple Myeloma, run by Etablissement Français du Sang.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Corrected count increment (time frame: 24 hours post transfusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2017.