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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

188 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-02

Study Completion Date

2024-05-21

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Observational Study of the Performance of Cephen Reagents in the Context of Research Into Lupus Anticoagulants

NCT05172778

Lupus Anticoagulant

UNKNOWN

Relation of Antibodies Against Oxidized Low Density Lipoproteins to Disease Activity and Cardiovascular Affection in Systemic Lupus.

NCT05479071

SLE

UNKNOWN

Immune Mediators and Metabolites to Stratify Systemic Lupus Erythematosus Patients at High Risk of Cardio Vascular Diseases

NCT04276701

Systemic Lupus Erythematosus

RECRUITING NA

Drug Therapy in Lupus Nephropathy

NCT00001212

Nephrotic Syndrome Systemic Lupus Erythematosus

COMPLETED PHASE2

A Study to Evaluate the Safety and Efficacy of Obinutuzumab Compared With Placebo in Participants With Lupus Nephritis (LN)

NCT02550652

Lupus Nephritis

COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Antiphospholipid Syndrome Anticoagulant Drugs

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

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-.

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Patients are recruited according to their LA status (LA- or LA+).

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Group/Cohort 1 :

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

Group Type OTHER

Lupus anticoagulant testing

Intervention Type DIAGNOSTIC_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.

Group/Cohort 2:

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

Group Type OTHER

Lupus anticoagulant testing

Intervention Type DIAGNOSTIC_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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Lupus anticoagulant testing

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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes