Antiphospholipid SyndromeANTICOLANCT05416190
Effect of Injectable Anticoagulants on Research for a Circulating Lupus-type Anticoagulant
A study testing Lupus anticoagulant testing in people with Antiphospholipid Syndrome and Anticoagulant Drugs, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial summary
The aim is to assess the effect of injectable anticoagulants (unfractionated heparin (UFH), low molecular weight heparins (LMWH), fondaparinux, danaparoid, argatroban) on lupus anticoagulant testing assays over broad anti-Xa activity ranges and to establish their potential for causing false-positive or false-negative… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Antiphospholipid Syndrome, Anticoagulant Drugs
- What is being tested?
- Lupus anticoagulant testing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 188 participants
- Where
- 1 siteFrance
- Study dates
- 2 Jun 2022to 21 May 2024
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- For all subjects:
- Adult male or female subject.
- In capacity to give informed consent to participate in the research.
- Affiliated to a Social Security system.
- For the LA- group:
- Without a previous thrombosis and considered healthy on the basis of the interview and clinical examination.
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- Without coagulation disease
- For the LA+ group:
- Notion of the presence of lupus anticoagulant (according to ISTH criteria) and whose last test was positive.
Who cannot join
- For all subjects:
- Medical history considered by the investigator to be incompatible with the trial
- Refused participation
- Recent administration of oral or injectable anticoagulants
- INR > 1.5
- Pregnant women, nursing mothers
- Guardianship, curatorship, deprived of liberty, safeguard of justice
Trial locations and contacts
1 site in 1 country.
About this study
The aim is to assess the effect of injectable anticoagulants (unfractionated heparin (UFH), low molecular weight heparins (LMWH), fondaparinux, danaparoid, argatroban) on lupus anticoagulant testing assays over broad anti-Xa activity ranges and to establish their potential for causing false-positive or false-negative results.
Read the detailed description
Citrated whole blood was collected from subjects with positive lupus anticoagulant (LA) testing and from subjects with negative LA testing. Injectable anticoagulants were prepared in demineralized water and added to plasma samples LA+ and LA- to obtain broad anti-Xa activity ranges. Anti-Xa measurement and LA testing were performed in neat and spiked plasma samples. LA testing was performed with 4 different analyzer-reagent combinations to represent almost all hemostasis manufacturers currently available. There will be no direct comparison between the LA+ and LA- groups, the objective is to evaluate the effect of increasing concentrations of injectable anticoagulants on these 2 distinct populations.
- Conditions
- Antiphospholipid Syndrome, Anticoagulant Drugs
- Being tested
- Lupus anticoagulant testing
- Keywords
- Lupus coagulation inhibitor, Anticoagulant drugs
- Medical subject headings
- Antiphospholipid Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lupus anticoagulant testingDiagnostic test
The patient will have a visit during which a blood sample will be taken, a clinical examination will be performed, and data will be collected.
| Study group | Role | What they receive |
|---|---|---|
| Group/Cohort 1 : | Other | Notion of the presence of lupus anticoagulant (according to ISTH criteria) and whose last test was positive Receives: Diagnostic Test: Lupus anticoagulant testing |
| Group/Cohort 2: | Other | Without a previous thrombosis and considered healthy on the basis of the interview and clinical examination. Without coagulation disease. Receives: Diagnostic Test: Lupus anticoagulant testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Results of lupus anticoagulant testing: positive or negative
Concerning the impact of injectable anticoagulants on the final diagnosis of LA testing (negative or positive), in a population of LA+ and LA- subjects, particular attention will be paid to the study of false negatives and false positives expressed in % and 95% confidence intervals.
Measured: day 1
Secondary outcomes (2)
Effect of injectable anticoagulants on the clotting times of each of the tests involved in LA testing (detection, mixing and confirmation tests).
comparison of clotting times in the absence and presence of increasing concentrations of anticoagulants will be carried out by Anova or non-parametric Kruskal-Wallis test if the conditions of Anova are not respected. Graphical representations will be associated with these analyses.
Measured: day 1
Determination of the threshold limits of injectable anticoagulants (anti-Xa activities) allowing a reliable LA diagnosis, for each analytical solution tested (analyzer/reagent combinations).
comparison of clotting times in the absence and presence of increasing concentrations of anticoagulants will be carried out by Anova or non-parametric Kruskal-Wallis test if the conditions of Anova are not respected.
Measured: day1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2022
- Study start2 Jun 2022
- Primary completion21 May 2024
- Study completion21 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Antiphospholipid SyndromeStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe sponsor's other registered studies.
- 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
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- Citrated whole blood was collected from all participants and lupus anticoagulant testing was performed before and after spiking in vitro injectable anticoagulants. No distinction between the groups LA+ and LA-.
- Masking
- None (open label)
- Enrolment
- 188 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Laurie TALON, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05416190
- Sponsor's protocol ID
- AOI 2021 TALON
- Other IDs
- 2021-A02743-38
- Acronym
- ANTICOLA
- Status last verified
- Jun 2022
- First submitted
- 12 May 2022
- Last updated
- 21 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Injectable Anticoagulants on Research for a Circulating Lupus-type Anticoagulant
- ClinicalTrials.gov ID
- NCT05416190
- Acronym / sponsor ID
- ANTICOLA / AOI 2021 TALON
- Conditions
- Antiphospholipid Syndrome, Anticoagulant Drugs
- Keywords
- Lupus coagulation inhibitor, Anticoagulant drugs
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 188 participants (actual)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- 2 Jun 2022 (actual)
- Primary completion
- 21 May 2024 (actual)
- Study completion
- 21 May 2024 (actual)
- First posted
- 13 Jun 2022 (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 aim is to assess the effect of injectable anticoagulants (unfractionated heparin (UFH), low molecular weight heparins (LMWH), fondaparinux, danaparoid, argatroban) on lupus anticoagulant testing assays over broad anti-Xa activity ranges and to establish their potential for causing false-positive or false-negative results.
Detailed description
Citrated whole blood was collected from subjects with positive lupus anticoagulant (LA) testing and from subjects with negative LA testing. Injectable anticoagulants were prepared in demineralized water and added to plasma samples LA+ and LA- to obtain broad anti-Xa activity ranges. Anti-Xa measurement and LA testing were performed in neat and spiked plasma samples. LA testing was performed with 4 different analyzer-reagent combinations to represent almost all hemostasis manufacturers currently available. There will be no direct comparison between the LA+ and LA- groups, the objective is to evaluate the effect of increasing concentrations of injectable anticoagulants on these 2 distinct populations.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Citrated whole blood was collected from all participants and lupus anticoagulant testing was performed before and after spiking in vitro injectable anticoagulants. No distinction between the groups LA+ and LA-.
| Arm | Type | Receives |
|---|---|---|
| Group/Cohort 1 : | Other | Diagnostic Test: Lupus anticoagulant testingNotion of the presence of lupus anticoagulant (according to ISTH criteria) and whose last test was positive |
| Group/Cohort 2: | Other | Diagnostic Test: Lupus anticoagulant testingWithout a previous thrombosis and considered healthy on the basis of the interview and clinical examination. Without coagulation disease. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- For all subjects:
- Adult male or female subject.
- In capacity to give informed consent to participate in the research.
- Affiliated to a Social Security system.
- Without a previous thrombosis and considered healthy on the basis of the interview and clinical examination.
Key exclusion criteria (7 listed)
- Medical history considered by the investigator to be incompatible with the trial
- Refused participation
- Recent administration of oral or injectable anticoagulants
- INR > 1.5
- Pregnant women, nursing mothers
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 |
|---|---|---|
| Lupus anticoagulant testingThe patient will have a visit during which a blood sample will be taken, a clinical examination will be performed, and data will be collected. | Diagnostic test | Group/Cohort 1 :, Group/Cohort 2: |
Primary outcome
Results of lupus anticoagulant testing: positive or negative
Time frame: day 1
Concerning the impact of injectable anticoagulants on the final diagnosis of LA testing (negative or positive), in a population of LA+ and LA- subjects, particular attention will be paid to the study of false negatives and false positives expressed in % and 95% confidence intervals.
2 secondary outcomes
Effect of injectable anticoagulants on the clotting times of each of the tests involved in LA testing (detection, mixing and confirmation tests).
Time frame: day 1
Determination of the threshold limits of injectable anticoagulants (anti-Xa activities) allowing a reliable LA diagnosis, for each analytical solution tested (analyzer/reagent combinations).
Time frame: day1
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 21 Jun 2024.
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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.
Laurie TALON principal investigator
University Hospital, Clermont-Ferrand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lupus anticoagulant testing in people with Antiphospholipid Syndrome and Anticoagulant Drugs, run by University Hospital, Clermont-Ferrand 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 9 inclusion and 7 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: finished, as of the sponsor's last update on 21 Jun 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?
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?
Results of lupus anticoagulant testing: positive or negative (time frame: day 1). 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 21 Jun 2024.