ACERTP: Platelet Transfusion Refractoriness

Sponsor

Institut de cancérologie Strasbourg Europe (Other)

Overall Status

Recruiting

CT.gov ID

NCT05399693

Collaborator

(none)

Enrollment

Location

5.9

Anticipated Duration (Months)

8.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Platelet Transfusion Refractoriness	Procedure: platelet transfusion

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

Study Type:

Observational

Anticipated Enrollment :

50 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Characterization of Anti-HLA I Antibodies Involved in Platelet Transfusion Refractoriness: Optimization of the Transfusion Management of Patients With Severe Thrombocytopenia

Actual Study Start Date :

Feb 2, 2022

Anticipated Primary Completion Date :

Aug 2, 2022

Anticipated Study Completion Date :

Aug 2, 2022

Arms and Interventions

Arm	Intervention/Treatment
Patients with Platelet Transfusion Refractoriness	Procedure: platelet transfusion platelet transfusion realised for Hematopoietic stem cells graft or for acute leukemia
Patients without Platelet Transfusion Refractoriness	Procedure: platelet transfusion platelet transfusion realised for Hematopoietic stem cells graft or for acute leukemia

Arm

Intervention/Treatment

Patients with Platelet Transfusion Refractoriness

Procedure: platelet transfusion

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

Patients without Platelet Transfusion Refractoriness

Procedure: platelet transfusion

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

Outcome Measures

Primary Outcome Measures

Research of predictive criteria of Platelet transfusion refractoriness [blood samples before the transfusion of each chemotherapy cycle]
Characterisation of anti-HLA I antibodies (recognised epitopes and isotypes) associated to Platelet transfusion refractoriness

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Institut de cancérologie Strasbourg Europe	Strasbourg		France

Sponsors and Collaborators

Institut de cancérologie Strasbourg Europe

Investigators

Principal Investigator: Luc FORNECKER, Institut de cancérologie Strasbourg Europe

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Institut de cancérologie Strasbourg Europe

ClinicalTrials.gov Identifier:

NCT05399693

Other Study ID Numbers:

2021-006

First Posted:

Jun 1, 2022

Last Update Posted:

Jun 1, 2022

Last Verified:

May 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Jun 1, 2022