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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05399693
Other study ID # 2021-006
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date February 2, 2022
Est. completion date November 2, 2023

Study information

Verified date September 2023
Source Institut de cancérologie Strasbourg Europe
Contact Manon VOEGELIN
Phone 03 68 33 95 23
Email promotion-rc@icans.eu
Is FDA regulated No
Health authority
Study type Observational

Clinical 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 50
Est. completion date November 2, 2023
Est. primary completion date November 2, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms

  • Platelet Transfusion Refractoriness

Intervention

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

Locations

Country Name City State
France Institut de cancérologie Strasbourg Europe Strasbourg

Sponsors (1)

Lead Sponsor Collaborator
Institut de cancérologie Strasbourg Europe

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
See also
  Status Clinical Trial Phase
Recruiting NCT05761457 - Efficacy and Safety of Autologous Cryopreserved Platelets in Patients With PTR N/A
Completed NCT02858323 - Complement (C1q) Binding to HLA Antibodies in a Solid-phase Immunoassay and Clinical Effect on Platelet Transfusion
Recruiting NCT06254560 - Rituximab for Serious Aplastic Anemia With Platelet Transfusion Refractoriness Phase 2
Recruiting NCT04846439 - Sequential Infusion of CD19 and BCMA CAR-T Cells to Improve PTR in Patients With AL Phase 1/Phase 2
Recruiting NCT05832216 - Efficacy of Daratumumab to Overcome Platelet Transfusion Refractoriness in Patients With Aplastic Anemia Phase 1