Transfusion ReactionNCT06543771
Clinical Performance Study of Safety Test ABO Device
A study testing Safety Test ABO and ABTest Card® 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 Safety Test ABO with the ABTest Card device. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Transfusion Reaction
- What is being tested?
- Safety Test ABO and ABTest Card®
- How many people
- 100 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 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*;
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- 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);
Who cannot join
- Pregnant woman;
- Person deprived of liberty;
- Unconscious person;
- Person under guardianship or trusteeship;
- For neonatal 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 Safety Test ABO with the ABTest Card device.
Read the 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 Council" [2], 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").
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 Safety Test ABO and ABTest Card® are already CE marked under Directive 98/79/EC as List IIA product, this study is part of the device's post-marketing performance monitoring.
- Conditions
- Transfusion Reaction
- Being tested
- Safety Test ABO and ABTest Card®
- Medical subject headings
- Transfusion Reaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Safety Test ABO and ABTest Card®Diagnostic test
Pre transfusional control with the Safety Test ABO device (reference device) and the ABTest Card® device (comparator).
What is being measured
The primary outcome is the main question the study is designed to answer.
Concordance obtained between blood type information from medical record and patient results obtained by Safety Test ABO.
Comparison of the "patient" blood type determined from the results of the Safety Test ABO device (A, B, AB, O) with the "patient" blood type in the medical record (A, B, AB, O).
Measured: 5 minutes.
Concordance obtained between blood bag labelling information and blood bag results obtained by Safety Test ABO.
Comparison of the "donor" blood type determined from the results of the Safety Test ABO device (A, B, AB, O) with the "donor" blood type shown on the blood bag label (A, B, AB, O).
Measured: 5 minutes.
Concordance obtained on patient blood type between Safety Test ABO and ABTest Card® results.
Comparison of the "patient" blood type determined from the results of the ABTest Card® device (A, B, AB, O) with the "patient" blood type determined from the results of the Safety Test ABO device (A, B, AB, O).
Measured: 5 minutes.
Concordance obtained on blood bag blood type between Safety Test ABO and ABTest Card® results.
Comparison of the "donor" blood type determined from the results of the ABTest Card® device (A, B, AB, O) with the "donor" blood type determined from the results of the Safety Test ABO device (A, B, AB, O).
Measured: 5 minutes.
Blood compatibility between blood bag and patient for the Safety Test ABO.
Comparison of the "patient" blood type determined from the results of the Safety Test ABO device (A, B, AB, O) with the "donor" blood type determined from the results of the Safety Test ABO device (A, B, AB, O).
Measured: 5 minutes.
Blood compatibility between blood bag and patient for the ABTest Card®.
Comparison of the "patient" blood type determined from the results of the ABTest Card® device (A, B, AB, O) with the "donor" blood type determined from the results of the ABTest Card® device (A, B, AB, O).
Measured: 5 minutes.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 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
- 100 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
- NCT06543771
- Sponsor's protocol ID
- CPSP_23-07
- Status last verified
- Jun 2024
- First submitted
- 19 Jun 2024
- Last updated
- 9 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 9 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Performance Study of Safety Test ABO Device
- ClinicalTrials.gov ID
- NCT06543771
- Acronym / sponsor ID
- CPSP_23-07
- Conditions
- Transfusion Reaction
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 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
- 9 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 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 Council" [2], 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").
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 Safety Test ABO and ABTest Card® are already CE marked under Directive 98/79/EC as List IIA product, this study is part of the device's post-marketing performance monitoring.
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 category:
- Have health care insurance;
- Have given his/her written consent (or legal representative in case of newborn);
Key exclusion criteria (5 listed)
- Pregnant woman;
- Person deprived of liberty;
- Unconscious person;
- Person under guardianship or trusteeship;
- For neonatal 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 |
|---|---|---|
| Safety Test ABO and ABTest Card®Pre transfusional control with the Safety Test ABO device (reference device) and the ABTest Card® device (comparator). | Diagnostic test | – |
Primary outcome
Concordance obtained between blood type information from medical record and patient results obtained by Safety Test ABO.
Time frame: 5 minutes.
Comparison of the "patient" blood type determined from the results of the Safety Test ABO device (A, B, AB, O) with the "patient" blood type in the medical record (A, B, AB, O).
Concordance obtained between blood bag labelling information and blood bag results obtained by Safety Test ABO.
Time frame: 5 minutes.
Comparison of the "donor" blood type determined from the results of the Safety Test ABO device (A, B, AB, O) with the "donor" blood type shown on the blood bag label (A, B, AB, O).
Concordance obtained on patient blood type between Safety Test ABO and ABTest Card® results.
Time frame: 5 minutes.
Comparison of the "patient" blood type determined from the results of the ABTest Card® device (A, B, AB, O) with the "patient" blood type determined from the results of the Safety Test ABO device (A, B, AB, O).
Concordance obtained on blood bag blood type between Safety Test ABO and ABTest Card® results.
Time frame: 5 minutes.
Comparison of the "donor" blood type determined from the results of the ABTest Card® device (A, B, AB, O) with the "donor" blood type determined from the results of the Safety Test ABO device (A, B, AB, O).
Blood compatibility between blood bag and patient for the Safety Test ABO.
Time frame: 5 minutes.
Comparison of the "patient" blood type determined from the results of the Safety Test ABO device (A, B, AB, O) with the "donor" blood type determined from the results of the Safety Test ABO device (A, B, AB, O).
Blood compatibility between blood bag and patient for the ABTest Card®.
Time frame: 5 minutes.
Comparison of the "patient" blood type determined from the results of the ABTest Card® device (A, B, AB, O) with the "donor" blood type determined from the results of the ABTest Card® device (A, B, AB, O).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 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 Safety Test ABO and ABTest Card® 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 9 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 between blood type information from medical record and patient results obtained by Safety Test ABO. (time frame: 5 minutes.). The study lists 6 primary outcomes in all. 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 9 Aug 2024.