NCT05399693

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 2, 2022

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

May 25, 2022

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 1, 2022

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 8, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 8, 2023

Completed
Last Updated

January 5, 2026

Status Verified

December 1, 2025

Enrollment Period

1.5 years

First QC Date

May 25, 2022

Last Update Submit

December 30, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Research of predictive criteria of Platelet transfusion refractoriness

    Characterisation of anti-HLA I antibodies (recognised epitopes and isotypes) associated to Platelet transfusion refractoriness

    blood samples before the transfusion of each chemotherapy cycle

Study Arms (2)

Patients with Platelet Transfusion Refractoriness

Procedure: platelet transfusion

Patients without Platelet Transfusion Refractoriness

Procedure: platelet transfusion

Interventions

platelet transfusion realised for Hematopoietic stem cells graft or for acute leukemia

Patients with Platelet Transfusion RefractorinessPatients without Platelet Transfusion Refractoriness

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Adult patient : * with Hematopoietic stem cells graft (autograft or allograft) * or with acute leukemia with the indication of platelet transfusion.

You may qualify if:

  • Adult patient with Hematopoietic stem cells graft (autograft or allograft) or with acute leukemia with the indication of platelet transfusion.

You may not qualify if:

  • Patient under guardianship
  • Minor patient

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institut de cancérologie Strasbourg Europe

Strasbourg, France

Location

Related Publications (1)

  • 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.

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples

MeSH Terms

Interventions

Platelet Transfusion

Intervention Hierarchy (Ancestors)

Blood Component TransfusionBlood TransfusionBiological TherapyTherapeutics

Study Officials

  • Luc FORNECKER

    Institut de cancérologie Strasbourg Europe

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 25, 2022

First Posted

June 1, 2022

Study Start

February 2, 2022

Primary Completion

August 8, 2023

Study Completion

August 8, 2023

Last Updated

January 5, 2026

Record last verified: 2025-12

Locations