- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05399693
Platelet Transfusion Refractoriness (ACERTP)
December 30, 2025 updated by: Institut de cancérologie Strasbourg Europe
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Observational
Enrollment (Actual)
50
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Strasbourg, France
- Institut de Cancérologie Strasbourg Europe
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Sampling Method
Probability Sample
Study Population
Adult patient :
- with Hematopoietic stem cells graft (autograft or allograft)
- or with acute leukemia with the indication of platelet transfusion.
Description
Inclusion Criteria:
- Adult patient with Hematopoietic stem cells graft (autograft or allograft) or with acute leukemia with the indication of platelet transfusion.
Exclusion Criteria:
- Patient under guardianship
- Minor patient
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Patients with Platelet Transfusion Refractoriness
|
platelet transfusion realised for Hematopoietic stem cells graft or for acute leukemia
|
|
Patients without Platelet Transfusion Refractoriness
|
platelet transfusion realised for Hematopoietic stem cells graft or for acute leukemia
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
blood samples before the transfusion of each chemotherapy cycle
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Luc FORNECKER, Institut de Cancérologie Strasbourg Europe
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 2, 2022
Primary Completion (Actual)
August 8, 2023
Study Completion (Actual)
August 8, 2023
Study Registration Dates
First Submitted
May 25, 2022
First Submitted That Met QC Criteria
May 30, 2022
First Posted (Actual)
June 1, 2022
Study Record Updates
Last Update Posted (Actual)
January 5, 2026
Last Update Submitted That Met QC Criteria
December 30, 2025
Last Verified
December 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2021-006
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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.