NCT05416190

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 188 (actual)
• Sponsor: University Hospital, Clermont-Ferrand · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Antiphospholipid Syndrome
• Anticoagulant Drugs

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	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.

Timeline

• Start date: 2022-06-02
• Primary completion: 2024-05-21
• Completion: 2024-05-21
• First posted: 2022-06-13
• Last updated: 2024-06-21

Locations

1 site across 1 country: France