ThrombocytopaeniaECLATNCT06805097
Clinical Efficacy of Platelet Transfusion
An observational study of Thrombocytopaenia and Haematological Malignancies, run by Centre Hospitalier Universitaire de Besancon at 1 site in France.
Trial summary
The aim of this study is to analyze the effect of the storage time of platelet concentrates on the occurrence of bleeding events during prophylactic platelet transfusions in patients with hematological malignancies. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thrombocytopaenia, Haematological Malignancies
- What is being tested?
- Self-assessment of bleeding events
- How many people
- 343 participants
- Where
- 1 siteFrance
- Study dates
- 17 Jun 2025to Jul 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: Patients treated for haematological malignancy with severe thrombocytopenia associated with bone marrow failure and requiring platelet transfusion
Who may be able to join
- Patients with haematological malignancies or bone marrow aplasia with severe thrombocytopenia due to bone marrow failure related to the disease or treatments received
- Severe thrombocytopenia requiring transfusion
- Patient able to self-assess bleeding events
- Non-opposition of the subject to participate in the study
- Registered with the French social security system or benefiting from such a system.
Who cannot join
- Acute promyelocytic leukaemia
- Curative dosage of anticoagulants
- Treatment with antiplatelet agents
- Patient with proven thrombocytopenia of immunological origin, or disseminated intravascular coagulation
- Patients with a clinically significant haemorrhagic event (WHO grade 2) in the 48 hours prior to transfusion
- Indication for deplasmatised, cryopreserved and reduced-volume PCs
Show all 11Show fewer
- Patient refusing transfusion of labile blood products
- Pregnant women or breast-feeding mothers
- Adults subject to a legal protection measure or unable to express their consent
- Persons deprived of their liberty by a judicial or administrative decision; persons under compulsory psychiatric care; persons admitted to a health or social care institution for purposes other than research
- Subject in the exclusion period of another study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHU Besançon
Besançon, 25000
Charline Vauchy, PhD., +33381218875, cvauchy@chu-besancon.fr
About this study
The aim of this study is to analyze the effect of the storage time of platelet concentrates on the occurrence of bleeding events during prophylactic platelet transfusions in patients with hematological malignancies.
Read the detailed description
Since 2017, the preparation processes and shelf life of platelet concentrates (PCs) have been changed to increase transfusion safety and optimise transfusion processes. These changes have led to an increase in the total number of PCs transfused, a decrease in the number of platelets per PC and an increase in the number of platelets transfused per patient. Previous studies have shown that longer storage of platelets contributes to less in vivo recirculation of transfused platelets. Studies of haemostatic efficacy have generally not reported a significant effect. However, the haemostatic efficacy of PC stored for more or less than 5 days has not been evaluated. The ECLAT multicentre prognostic cohort study will prospectively and comparatively evaluate the haemorrhagic event in haematology patients with severe thrombocytopenia transfused according to the duration of PC storage.
- Conditions
- Thrombocytopaenia, Haematological Malignancies
- Being tested
- Self-assessment of bleeding events
- Keywords
- platelet concentrate, transfusion, haemorrhage
- Medical subject headings
- Thrombocytopenia, Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-assessment of bleeding eventsOther
After each transfusion, the patient completes a daily bleeding event self-assessment (adapted from the WHO bleeding event scale) until the next transfusion or over a period of 10 days.
| Study group | Role | What they receive |
|---|---|---|
| Patients with severe thrombocytopenia | Patients with haematological malignancies who have severe thrombocytopenia associated with bone marrow failure requiring platelet transfusion and who are able to self-assess bleeding events. Receives: Other: Self-assessment of bleeding events |
What is being measured
The primary outcome is the main question the study is designed to answer.
Grade 2 or higher bleeding event
Grade 2 or higher bleeding event, depending on platelet shelf life.
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 posted3 Feb 2025
- Study start17 Jun 2025
- Primary completionJul 2028 (estimated)
- Study completionJul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ThrombocytopaeniaStudies 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
- Prospective
- Enrolment
- 343 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Besancon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06805097
- Sponsor's protocol ID
- 2025/934
- Acronym
- ECLAT
- Status last verified
- Jul 2025
- First submitted
- 28 Jan 2025
- Last updated
- 9 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Efficacy of Platelet Transfusion
- ClinicalTrials.gov ID
- NCT06805097
- Acronym / sponsor ID
- ECLAT / 2025/934
- Conditions
- Thrombocytopaenia, Haematological Malignancies
- Keywords
- platelet concentrate, transfusion, haemorrhage
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 343 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de BesanconUniversity, hospital or other
- Study start
- 17 Jun 2025 (actual)
- Primary completion
- Jul 2028 (estimated)
- Study completion
- Jul 2028 (estimated)
- First posted
- 3 Feb 2025 (actual)
- 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.
The aim of this study is to analyze the effect of the storage time of platelet concentrates on the occurrence of bleeding events during prophylactic platelet transfusions in patients with hematological malignancies.
Detailed description
Since 2017, the preparation processes and shelf life of platelet concentrates (PCs) have been changed to increase transfusion safety and optimise transfusion processes. These changes have led to an increase in the total number of PCs transfused, a decrease in the number of platelets per PC and an increase in the number of platelets transfused per patient. Previous studies have shown that longer storage of platelets contributes to less in vivo recirculation of transfused platelets. Studies of haemostatic efficacy have generally not reported a significant effect. However, the haemostatic efficacy of PC stored for more or less than 5 days has not been evaluated. The ECLAT multicentre prognostic cohort study will prospectively and comparatively evaluate the haemorrhagic event in haematology patients with severe thrombocytopenia transfused according to the duration of PC storage.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with severe thrombocytopenia | – | Other: Self-assessment of bleeding eventsPatients with haematological malignancies who have severe thrombocytopenia associated with bone marrow failure requiring platelet transfusion and who are able to self-assess bleeding events. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients treated for haematological malignancy with severe thrombocytopenia associated with bone marrow failure and requiring platelet transfusion
Key inclusion criteria (5 listed)
- Patients with haematological malignancies or bone marrow aplasia with severe thrombocytopenia due to bone marrow failure related to the disease or treatments received
- Severe thrombocytopenia requiring transfusion
- Patient able to self-assess bleeding events
- Non-opposition of the subject to participate in the study
- Registered with the French social security system or benefiting from such a system.
Key exclusion criteria (11 listed)
- Acute promyelocytic leukaemia
- Curative dosage of anticoagulants
- Treatment with antiplatelet agents
- Patient with proven thrombocytopenia of immunological origin, or disseminated intravascular coagulation
- Patients with a clinically significant haemorrhagic event (WHO grade 2) in the 48 hours prior to transfusion
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 |
|---|---|---|
| Self-assessment of bleeding eventsAfter each transfusion, the patient completes a daily bleeding event self-assessment (adapted from the WHO bleeding event scale) until the next transfusion or over a period of 10 days. | Other | Patients with severe thrombocytopenia |
Primary outcome
Grade 2 or higher bleeding event
Time frame: 7 days
Grade 2 or higher bleeding event, depending on platelet shelf life.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2025.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Thrombocytopaenia and Haematological Malignancies, run by Centre Hospitalier Universitaire de Besancon at 1 site in France.
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 5 inclusion and 11 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: looking for participants now, as of the sponsor's last update on 9 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Charline Vauchy, PhD. (+33381218875, cvauchy@chu-besancon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Grade 2 or higher bleeding event (time frame: 7 days). 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 9 Jul 2025.