search
Back to results

Effect of Injectable Anticoagulants on Research for a Circulating Lupus-type Anticoagulant (ANTICOLA)

Primary Purpose

Antiphospholipid Syndrome, Anticoagulant Drugs

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Lupus anticoagulant testing
Sponsored by
University Hospital, Clermont-Ferrand
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Antiphospholipid Syndrome focused on measuring Lupus coagulation inhibitor, Anticoagulant drugs

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 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.
  • Without coagulation disease

For the LA+ group:

- Notion of the presence of lupus anticoagulant (according to ISTH criteria) and whose last test was positive.

Exclusion Criteria:

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

Sites / Locations

  • CHU clermont-ferrandRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Group/Cohort 1 :

Group/Cohort 2:

Arm Description

Notion of the presence of lupus anticoagulant (according to ISTH criteria) and whose last test was positive

Without a previous thrombosis and considered healthy on the basis of the interview and clinical examination. Without coagulation disease.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
May 12, 2022
Last Updated
June 13, 2022
Sponsor
University Hospital, Clermont-Ferrand
search

1. Study Identification

Unique Protocol Identification Number
NCT05416190
Brief Title
Effect of Injectable Anticoagulants on Research for a Circulating Lupus-type Anticoagulant
Acronym
ANTICOLA
Official Title
Effect of Injectable Anticoagulants on Research for a Circulating Lupus-type Anticoagulant
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 2, 2022 (Actual)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Clermont-Ferrand

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Antiphospholipid Syndrome, Anticoagulant Drugs
Keywords
Lupus coagulation inhibitor, Anticoagulant drugs

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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)
Masking Description
Patients are recruited according to their LA status (LA- or LA+).
Allocation
Non-Randomized
Enrollment
336 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group/Cohort 1 :
Arm Type
Other
Arm Description
Notion of the presence of lupus anticoagulant (according to ISTH criteria) and whose last test was positive
Arm Title
Group/Cohort 2:
Arm Type
Other
Arm Description
Without a previous thrombosis and considered healthy on the basis of the interview and clinical examination. Without coagulation disease.
Intervention Type
Diagnostic Test
Intervention Name(s)
Lupus anticoagulant testing
Intervention Description
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.
Primary Outcome Measure Information:
Title
Results of lupus anticoagulant testing: positive or negative
Description
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.
Time Frame
day 1
Secondary Outcome Measure Information:
Title
Effect of injectable anticoagulants on the clotting times of each of the tests involved in LA testing (detection, mixing and confirmation tests).
Description
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.
Time Frame
day 1
Title
Determination of the threshold limits of injectable anticoagulants (anti-Xa activities) allowing a reliable LA diagnosis, for each analytical solution tested (analyzer/reagent combinations).
Description
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.
Time Frame
day1

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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. Without coagulation disease For the LA+ group: - Notion of the presence of lupus anticoagulant (according to ISTH criteria) and whose last test was positive. Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lise Laclautre
Phone
334.73.754.963
Email
promo_interne_drci@chu-clermontferrand.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Laurie TALON
Organizational Affiliation
University Hospital, Clermont-Ferrand
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU clermont-ferrand
City
Clermont-Ferrand
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lise Laclautre
First Name & Middle Initial & Last Name & Degree
Laurie TALON

12. IPD Sharing Statement

Learn more about this trial

Effect of Injectable Anticoagulants on Research for a Circulating Lupus-type Anticoagulant

We'll reach out to this number within 24 hrs