Status:
NOT_YET_RECRUITING
Clinical Performance Study of Safety Test ABO 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 Safety Test ABO with the ABTest Card device.
Detailed Description
According to the regulatory text "Common specifications for certain class D in vitro diagnostic medical devices in accordance with Regulation (EU) 2017/746 of the European Parliament and of the Counci...
Eligibility Criteria
Inclusion
- Age ≥ 18 years old for the category marked with \*.
- Undergo capillary blood sampling;
- Belong to one of the clinical category:
- 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 (eg. cancer), or undergoing haemodialysis\*;
- Patient with cold agglutinin\*;
- Premature patient with gestational age \< 37 weeks of newborn ≤27 days old in need of blood transfusion;
- Newborn eligible for Guthrie Test;
- Newborn eligible for glycemic test.
- Have health care insurance;
- Have given his/her written consent (or legal representative in case of newborn);
Exclusion
- Pregnant woman;
- Person deprived of liberty;
- Unconscious person;
- Person under guardianship or trusteeship;
- For neonatal 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 :
100 Patients enrolled
Trial Details
Trial ID
NCT06543771
Start Date
September 1 2024
End Date
January 1 2025
Last Update
August 9 2024
Active Locations (1)
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1
CHU Montpellier
Montpellier, France