Transfusion ReactionNCT06557031
Clinical Performance Study of the ABTest Card® Device.
A study testing ABTest Card®REF and ABTest Card®NEW in people with Transfusion Reaction, run by Diagast at 1 site in France.
Trial summary
The study aims to confirm the performance equivalence of the in vitro diagnostic device ABTest Card®REF with the ABTest Card®NEW device. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Transfusion Reaction
- What is being tested?
- ABTest Card®REF and ABTest Card®NEW
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2024to Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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* ;
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- 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) ;
Who cannot join
- Pregnant woman ;
- Person deprived of liberty ;
- Unconscious person ;
- Person under guardianship or trusteeship ;
- For paediatric clinical category: age ≥28 days and <18 years old.
Trial locations and contacts
1 site in 1 country.
About this study
The study aims to confirm the performance equivalence of the in vitro diagnostic device ABTest Card®REF with the ABTest Card®NEW device.
Read the 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, Blue dye and the blood segment opener device.
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 Council", 90% of the results will be derived from the performance study carried out at the DIAGAST laboratory on tube left over and blood bag, and 10% of the results will be derived from the use of the device in a real situation ("at the bedside").
The Regulation 2017/746 (IVDR) on IVDMD, has been effective since May 2022 with transitional periods. The IVDR replaces the current EU Directive (98/79/EC) to ensure a higher level of health and safety for the making available and putting into service of medical devices on the EU market. As the ABTest Card® is already CE marked under Directive 98/79/EC as List IIA product, this study is part of the device's post-marketing performance monitoring.
The purpose of this study is to document and verify the clinical performance of the ABTest Card® device in combination with the new raw materials used for manufacturing (ABTest Card®NEW), by comparing the results obtained with the ABTest Card®REF, already commercialised and used routinely by the study sites.
- Conditions
- Transfusion Reaction
- Being tested
- ABTest Card®REF and ABTest Card®NEW
- Medical subject headings
- Transfusion Reaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ABTest Card®REF and ABTest Card®NEWDiagnostic test
Pre transfusional control with the ABTest Card®REF device (predicate device) and the ABTest Card®NEW device (investigational device).
What is being measured
The primary outcome is the main question the study is designed to answer.
Concordance obtained on patient blood type between ABTest Card®NEW and ABTest Card®REF results.
Comparison of the "patient" blood type determined from the results of the ABTest Card®NEW device (A, B, AB, O) with the "patient" blood type determined from the results of the ABTest Card®REF device (A, B, AB, O).
There is concordance if the two "patient" blood types are identical.
Measured: 1 day.
Secondary outcomes (5)
Concordance obtained on blood bag blood type between the ABTest Card®NEW and ABTest Card®REF results.
Comparison of the "donor" blood type determined from the results of the ABTest Card®NEW device (A, B, AB, O) with the "donor" blood type determined from the results of the ABTest Card®REF device (A, B, AB, O).
There is concordance if the two "donor" blood types are identical.
Measured: 1 day.
Concordance obtained between blood type information from medical record and patient results obtained by ABTest Card®REF.
Comparison of the "patient" blood type determined from the results of the ABTest Card®REF device (A, B, AB, O) with the "patient" blood type in the medical record (A, B, AB, O).
There is concordance if the two "patient" blood types are identical.
Measured: 1 day.
Concordance obtained between blood bag labelling information and blood bag results obtained by ABTest Card®REF.
Comparison of the "donor" blood type determined from the results of the ABTest Card®REF device (A, B, AB, O) with the "donor" blood type shown on the blood bag label (A, B, AB, O).
There is concordance if the two "donor" blood types are identical.
Measured: 1 day.
Blood compatibility between the blood bag and the patient for the ABTest Card®NEW.
Comparison of the "patient" blood type determined from the results of the ABTest Card®NEW device (A, B, AB, O) with the "donor" blood type determined from the results of the ABTest Card®NEW device (A, B, AB, O).
There is blood compatibility if the two blood types follow specific associations.
Measured: 1 day.
Blood compatibility between the blood bag and the patient for the ABTest Card®REF.
Comparison of the "patient" blood type determined from the results of the ABTest Card®REF device (A, B, AB, O) with the "donor" blood type determined from the results of the ABTest Card®REF device (A, B, AB, O).
There is blood compatibility if the two blood types follow specific associations.
Measured: 1 day.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2024
- Study startSep 2024 (estimated)
- Primary completionJan 2025 (estimated)
- Study completionJan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Transfusion ReactionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- In situ used for near patient In vitro Medical device.
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Diagast
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Soladis
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06557031
- Sponsor's protocol ID
- CPSP_23-03
- Status last verified
- Aug 2024
- First submitted
- 7 Aug 2024
- Last updated
- 16 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Performance Study of the ABTest Card® Device.
- ClinicalTrials.gov ID
- NCT06557031
- Acronym / sponsor ID
- CPSP_23-03
- Conditions
- Transfusion Reaction
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- DiagastIndustry (pharma, biotech, devices)
- Collaborators
- Soladis
- Study start
- Sep 2024 (estimated)
- Primary completion
- Jan 2025 (estimated)
- Study completion
- Jan 2025 (estimated)
- First posted
- 16 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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, Blue dye and the blood segment opener device.
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 Council", 90% of the results will be derived from the performance study carried out at the DIAGAST laboratory on tube left over and blood bag, and 10% of the results will be derived from the use of the device in a real situation ("at the bedside").
The Regulation 2017/746 (IVDR) on IVDMD, has been effective since May 2022 with transitional periods. The IVDR replaces the current EU Directive (98/79/EC) to ensure a higher level of health and safety for the making available and putting into service of medical devices on the EU market. As the ABTest Card® is already CE marked under Directive 98/79/EC as List IIA product, this study is part of the device's post-marketing performance monitoring.
The purpose of this study is to document and verify the clinical performance of the ABTest Card® device in combination with the new raw materials used for manufacturing (ABTest Card®NEW), by comparing the results obtained with the ABTest Card®REF, already commercialised and used routinely by the study sites.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Model description
- In situ used for near patient In vitro Medical device.
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (12 listed)
- 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)* ;
Key exclusion criteria (5 listed)
- Pregnant woman ;
- Person deprived of liberty ;
- Unconscious person ;
- Person under guardianship or trusteeship ;
- For paediatric clinical category: age ≥28 days and <18 years old.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ABTest Card®REF and ABTest Card®NEWPre transfusional control with the ABTest Card®REF device (predicate device) and the ABTest Card®NEW device (investigational device). | Diagnostic test | – |
Primary outcome
Concordance obtained on patient blood type between ABTest Card®NEW and ABTest Card®REF results.
Time frame: 1 day.
Comparison of the "patient" blood type determined from the results of the ABTest Card®NEW device (A, B, AB, O) with the "patient" blood type determined from the results of the ABTest Card®REF device (A, B, AB, O). There is concordance if the two "patient" blood types are identical.
5 secondary outcomes
Concordance obtained on blood bag blood type between the ABTest Card®NEW and ABTest Card®REF results.
Time frame: 1 day.
Concordance obtained between blood type information from medical record and patient results obtained by ABTest Card®REF.
Time frame: 1 day.
Concordance obtained between blood bag labelling information and blood bag results obtained by ABTest Card®REF.
Time frame: 1 day.
Blood compatibility between the blood bag and the patient for the ABTest Card®NEW.
Time frame: 1 day.
Blood compatibility between the blood bag and the patient for the ABTest Card®REF.
Time frame: 1 day.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ABTest Card®REF and ABTest Card®NEW in people with Transfusion Reaction, run by Diagast at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Céline BOURIEZ (+33 (0) 3.20.96.53.86, regulatory@diagast.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Concordance obtained on patient blood type between ABTest Card®NEW and ABTest Card®REF results. (time frame: 1 day.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Aug 2024.