Status:
NOT_YET_RECRUITING
Clinical Performance Study of the ABTest Card® Device.
Lead Sponsor:
Diagast
Collaborating Sponsors:
Soladis
Conditions:
Transfusion Reaction
Eligibility:
All Genders
Phase:
NA
Brief Summary
The study aims to confirm the performance equivalence of the in vitro diagnostic device ABTest Card®REF with the ABTest Card®NEW device.
Detailed Description
Following some changes in the ABTest Card® raw materials, a new validation of the associated clinical performances is required. Raw materials of the ABTest Card® are : Triton, Cleanis, Tween, Yellow, ...
Eligibility Criteria
Inclusion
- Age ≥ 18 years old for the category marked with \*.
- Undergo capillary blood sampling ;
- Belong to one of the clinical categories:
- Patient in need of blood transfusion without any pathology known to have an impact on transfusion act\* ;
- Patient in need of blood transfusion suffering from congenital erythrocyte pathology (sickle cell anaemia, beta thalassemia)\* ;
- Patient in need of blood transfusion suffering from haematology disease (e.g. cancer), or undergoing haemodialysis\* ;
- Patient with cold agglutinin\* ;
- Premature patient with gestational age \< 37 weeks or newborn ≤27 days old in need of blood transfusion ;
- Newborn eligible for the Guthrie Test ;
- Newborn eligible for the glycaemic test.
- Have health care insurance ;
- Have given his/her written consent (or legal representative in the case of a newborn) ;
Exclusion
- Pregnant woman ;
- Person deprived of liberty ;
- Unconscious person ;
- Person under guardianship or trusteeship ;
- For paediatric clinical category: age ≥28 days and \<18 years old.
Key Trial Info
Start Date :
September 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2025
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT06557031
Start Date
September 1 2024
End Date
January 1 2025
Last Update
August 16 2024
Active Locations (1)
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1
CHU Orléans
Orléans, France