Platelet Transfusion RefractorinessACERTPNCT05399693
Platelet Transfusion Refractoriness
An observational study of Platelet Transfusion Refractoriness, run by Institut de cancérologie Strasbourg Europe at 1 site in France.
Trial summary
Platelet Transfusion Refractoriness is one of the severe complications after multiple transfusions in patients with severe thrombopenia. Platelet Transfusion Refractoriness is characterized by inefficient transfusion and arise from allo-antibodies specific of platelets antigenes, mostly carried by HLA-I molecules. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Platelet Transfusion Refractoriness
- What is being tested?
- platelet transfusion
- Type of treatment
- Surgery or procedure
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 2 Feb 2022to 8 Aug 2023
- 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: Adult patient : * with Hematopoietic stem cells graft (autograft or allograft) * or with acute leukemia with the indication of platelet transfusion.
Who may be able to join
- Adult patient with Hematopoietic stem cells graft (autograft or allograft) or with acute leukemia with the indication of platelet transfusion.
Who cannot join
- Patient under guardianship
- Minor patient
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Characterization of Anti-HLA I Antibodies Involved in Platelet Transfusion Refractoriness: Optimization of the Transfusion Management of Patients With Severe Thrombocytopenia
Platelet Transfusion Refractoriness is one of the severe complications after multiple transfusions in patients with severe thrombopenia. Platelet Transfusion Refractoriness is characterized by inefficient transfusion and arise from allo-antibodies specific of platelets antigenes, mostly carried by HLA-I molecules.
Read the detailed description
A preliminary study has shown different isotypes of anti-HLA I in patients with Platelet Transfusion Refractoriness. Our hypothesis is that the type of anti-HLA I antibodies (recognised epitope, quantity, isotype) should establish predictive and diagnostic criteria for Platelet Transfusion Refractoriness.
- Conditions
- Platelet Transfusion Refractoriness
- Being tested
- platelet transfusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
platelet transfusionProcedure or surgery
platelet transfusion realised for Hematopoietic stem cells graft or for acute leukemia
| Study group | Role | What they receive |
|---|---|---|
| Patients with Platelet Transfusion Refractoriness | Not described Receives: Procedure: platelet transfusion | |
| Patients without Platelet Transfusion Refractoriness | Not described Receives: Procedure: platelet transfusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Research of predictive criteria of Platelet transfusion refractoriness
Characterisation of anti-HLA I antibodies (recognised epitopes and isotypes) associated to Platelet transfusion refractoriness
Measured: blood samples before the transfusion of each chemotherapy cycle
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2022
- Study start2 Feb 2022
- Primary completion8 Aug 2023
- Study completion8 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Platelet Transfusion RefractorinessStudies 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
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut de cancérologie Strasbourg Europe
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Luc FORNECKER, Principal investigator, Institut de cancérologie Strasbourg Europe
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05399693
- Sponsor's protocol ID
- 2021-006
- Acronym
- ACERTP
- Status last verified
- Dec 2025
- First submitted
- 25 May 2022
- Last updated
- 5 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Couvidou A, Wald M, Angenieux C, Pires-Marafon J, Apithy MJ, Humbrecht C, Fornecker LM, Congy-Jolivet N, Dupuis A, Rollin J, Maitre B. Anti-HLA class I IgG subclasses skew platelet activation mechanisms in transfusion refractoriness. Haematologica. 2026 Feb 1;111(2):535-545. doi: 10.3324/haematol.2025.287677. Epub 2025 Sep 18.
PubMed 40963382
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterization of Anti-HLA I Antibodies Involved in Platelet Transfusion Refractoriness: Optimization of the Transfusion Management of Patients With Severe Thrombocytopenia
- ClinicalTrials.gov ID
- NCT05399693
- Acronym / sponsor ID
- ACERTP / 2021-006
- Conditions
- Platelet Transfusion Refractoriness
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Institut de cancérologie Strasbourg EuropeUniversity, hospital or other
- Study start
- 2 Feb 2022 (actual)
- Primary completion
- 8 Aug 2023 (actual)
- Study completion
- 8 Aug 2023 (actual)
- First posted
- 1 Jun 2022 (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.
Platelet Transfusion Refractoriness is one of the severe complications after multiple transfusions in patients with severe thrombopenia. Platelet Transfusion Refractoriness is characterized by inefficient transfusion and arise from allo-antibodies specific of platelets antigenes, mostly carried by HLA-I molecules.
Detailed description
A preliminary study has shown different isotypes of anti-HLA I in patients with Platelet Transfusion Refractoriness. Our hypothesis is that the type of anti-HLA I antibodies (recognised epitope, quantity, isotype) should establish predictive and diagnostic criteria for Platelet Transfusion Refractoriness.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with Platelet Transfusion Refractoriness | – | Procedure: platelet transfusion |
| Patients without Platelet Transfusion Refractoriness | – | Procedure: platelet transfusion |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patient : * with Hematopoietic stem cells graft (autograft or allograft) * or with acute leukemia with the indication of platelet transfusion.
Key inclusion criteria (1 listed)
- Adult patient with Hematopoietic stem cells graft (autograft or allograft) or with acute leukemia with the indication of platelet transfusion.
Key exclusion criteria (2 listed)
- Patient under guardianship
- Minor patient
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 transfusionplatelet transfusion realised for Hematopoietic stem cells graft or for acute leukemia | Procedure or surgery | Patients with Platelet Transfusion Refractoriness, Patients without Platelet Transfusion Refractoriness |
Primary outcome
Research of predictive criteria of Platelet transfusion refractoriness
Time frame: blood samples before the transfusion of each chemotherapy cycle
Characterisation of anti-HLA I antibodies (recognised epitopes and isotypes) associated to Platelet transfusion refractoriness
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 5 Jan 2026.
- Derived from this study: PubMed 40963382Couvidou A, Wald M, Angenieux C, Pires-Marafon J, Apithy MJ, Humbrecht C, Fornecker LM, Congy-Jolivet N, Dupuis A, Rollin J, Maitre B. Anti-HLA class I IgG subclasses skew platelet activation mechanisms in transfusion refractoriness. Haematologica. 2026 Feb 1;111(2):535-545. doi: 10.3324/haematol.2025.287677. Epub 2025 Sep 18.
Related trials for Platelet Transfusion Refractoriness
RecruitingPhase 1
RN1201 Injection in the Treatment of Antibody-Mediated Diseases
Refractory Immune-mediated Platelet Transfusion Refractoriness, Relapsed or Refractory Immune Thrombocytopenia
Not yet recruitingPhase 3
Acalabrutinib Maleate and Bortezomib for Patients With HLA Antibodies
Hematological Malignancies, Platelet Transfusion Refractoriness (PTR)
RecruitingPhase 1/2
Study of CM313(SC) Injection in Subjects With Platelet Transfusion Refractoriness
Platelet Transfusion Refractoriness
RecruitingPhase 2
Rituximab for Serious Aplastic Anemia With Platelet Transfusion Refractoriness
Severe Aplastic Anemia, Platelet Transfusion Refractoriness
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.
Luc FORNECKER principal investigator
Institut de cancérologie Strasbourg Europe
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 Platelet Transfusion Refractoriness, run by Institut de cancérologie Strasbourg Europe 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 1 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 5 Jan 2026. 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?
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?
Research of predictive criteria of Platelet transfusion refractoriness (time frame: blood samples before the transfusion of each chemotherapy cycle). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05399693, which also lists 1 linked publication.
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 5 Jan 2026.