Not Yet RecruitingNot Applicable

Clinical Performance Study of Safety Test ABO Device

France100 participantsStarted 2024-09

Plain-language summary

The study aims to confirm the performance equivalence of the in vitro diagnostic device Safety Test ABO with the ABTest Card device.

Who can participate

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Concordance obtained between blood type information from medical record and patient results obtained by Safety Test ABO.

Timeframe: 5 minutes.

Concordance obtained between blood bag labelling information and blood bag results obtained by Safety Test ABO.

Timeframe: 5 minutes.

Concordance obtained on patient blood type between Safety Test ABO and ABTest Card® results.

Timeframe: 5 minutes.

Concordance obtained on blood bag blood type between Safety Test ABO and ABTest Card® results.

Timeframe: 5 minutes.

Blood compatibility between blood bag and patient for the Safety Test ABO.

Timeframe: 5 minutes.

Blood compatibility between blood bag and patient for the ABTest Card®.

Timeframe: 5 minutes.

Trial details

NCT IDNCT06543771

SponsorDiagast

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-01

Contact for this trial

Céline BOURIEZ

+33 (0) 3.20.96.53.86 regulatory@diagast.com

View on ClinicalTrials.gov More Transfusion Reaction trials

Who can participate

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Concordance obtained between blood type information from medical record and patient results obtained by Safety Test ABO.

Timeframe: 5 minutes.

Concordance obtained between blood bag labelling information and blood bag results obtained by Safety Test ABO.

Timeframe: 5 minutes.

Concordance obtained on patient blood type between Safety Test ABO and ABTest Card® results.

Timeframe: 5 minutes.

Concordance obtained on blood bag blood type between Safety Test ABO and ABTest Card® results.

Timeframe: 5 minutes.

Blood compatibility between blood bag and patient for the Safety Test ABO.

Timeframe: 5 minutes.

Blood compatibility between blood bag and patient for the ABTest Card®.

Timeframe: 5 minutes.