Transfusion ReactionNCT05140395
ABTEST© Card Clinical Perfomance Study
A study testing ABTEST card in people with Transfusion Reaction, run by Diagast at 1 site in France.
Trial summary
The study confirms the performance equivalence of the in vitro Diagnostic reagent ABTEST card used with the new reformulated WS solution Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Transfusion Reaction
- What is being tested?
- ABTEST card
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 6 Jun 2021to 4 Nov 2021
- 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
66 patients in hematology / oncology departments , including 20 patients with a hemoglobin significantly below the norm (<8g / dl hemoglobin in the blood), and about to receive a transfusion. 20 patients hospitalized in gastroenterology with a transfusion need 4 internal medicine patients with cold agglutinins, in a transfusion context or not.
10 neonatal patients, background transfusion or Guthrie test.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Perfomance Study of the ABTEST© Card in Vitro Medical Device
The study confirms the performance equivalence of the in vitro Diagnostic reagent ABTEST card used with the new reformulated WS solution
Read the detailed description
The study consists to perform on 100 patients a first pre transfusional control with the reference in vitro reagent ABTEST card (CE Marked reagent) followed by a another pre transfusional control with the in vitro reagent ABTEST card in study (new reformulated WS solution used) .
- Conditions
- Transfusion Reaction
- Being tested
- ABTEST card
- Keywords
- Reagent Kits, Diagnostic
- Medical subject headings
- Transfusion Reaction, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ABTEST cardDiagnostic test
Pre transfusional control with the referent ABTEST card and the in study ABDTEST Card
| Study group | Role | What they receive |
|---|---|---|
| Pre transfusion control | Experimental | Pre control transfusion with the referent reagent and the in study reagent Receives: Diagnostic Test: ABTEST card |
What is being measured
The primary outcome is the main question the study is designed to answer.
Agreement between two reagents
performance of pre transfusional controls with the referent reagent and the reagent in study
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 posted1 Dec 2021
- Study start6 Jun 2021
- Primary completion28 Oct 2021
- Study completion4 Nov 2021
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 (actual)
Sponsor and investigators
- Lead sponsor
- Diagast
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pascal Huchette, phD, Principal investigator, CH Arras
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05140395
- Sponsor's protocol ID
- CPSP_20-01_V1
- Status last verified
- Nov 2021
- First submitted
- 19 Nov 2021
- Last updated
- 1 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Perfomance Study of the ABTEST© Card in Vitro Medical Device
- ClinicalTrials.gov ID
- NCT05140395
- Acronym / sponsor ID
- CPSP_20-01_V1
- Conditions
- Transfusion Reaction
- Keywords
- Reagent Kits, Diagnostic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- DiagastIndustry (pharma, biotech, devices)
- Study start
- 6 Jun 2021 (actual)
- Primary completion
- 28 Oct 2021 (actual)
- Study completion
- 4 Nov 2021 (actual)
- First posted
- 1 Dec 2021 (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 confirms the performance equivalence of the in vitro Diagnostic reagent ABTEST card used with the new reformulated WS solution
Detailed description
The study consists to perform on 100 patients a first pre transfusional control with the reference in vitro reagent ABTEST card (CE Marked reagent) followed by a another pre transfusional control with the in vitro reagent ABTEST card in study (new reformulated WS solution used) .
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- in situ used for near patient In vitro Medical device
| Arm | Type | Receives |
|---|---|---|
| Pre transfusion control | Experimental | Diagnostic Test: ABTEST cardPre control transfusion with the referent reagent and the in study reagent |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
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 cardPre transfusional control with the referent ABTEST card and the in study ABDTEST Card | Diagnostic test | Pre transfusion control |
Primary outcome
Agreement between two reagents
Time frame: 5 minutes
performance of pre transfusional controls with the referent reagent and the reagent in study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2021.
- Individual participant dataSharing planned: No
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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.
Pascal Huchette, phD principal investigator
CH Arras
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 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.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Dec 2021. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Agreement between two reagents (time frame: 5 minutes). 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 1 Dec 2021.