Clinical Performance Study of Safety Test ABO Device

Launched by DIAGAST · Aug 6, 2024

Keywords

ClinConnect Summary

This clinical trial is evaluating a new device called the Safety Test ABO, which is designed to help ensure that blood transfusions are safe for patients. The goal is to see how well this new device performs compared to an existing test called the ABTest Card. The study will not be recruiting participants just yet, but it is open to adults and certain newborns who need blood transfusions.

To be eligible for this trial, participants should be at least 18 years old and require a blood transfusion due to various medical conditions, such as blood disorders or needing dialysis. Newborns who are premature or need specific tests may also qualify. Participants will need to have health insurance and give their consent to join the trial. It's important to note that pregnant women and people who are unconscious or under guardianship cannot participate. If you join, you can expect to undergo a blood test using the new device and help researchers understand its effectiveness in making transfusions safer.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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 Criteria:
• • Pregnant woman;
• • Person deprived of liberty;
• • Unconscious person;
• • Person under guardianship or trusteeship;
• • For neonatal clinical category: age ≥28 days and \<18 years old.