Interest of High-speed Centrifugation for Measuring Anti-Xa Activity on Lipemic Plasma

NCT07200674 | Recruiting

• 1 other identifier: 9241
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

Some hemostasis techniques require spectrophotometric measurements. These are then subject to interference from the sample's lipemia (postprandial, hypertriglyceridemia, etc.), which risks distorting the results; this is estimated to affect 0.5 to 2.5% of samples. This is particularly the case for anti-Xa activity, a critical test used to monitor anticoagulant treatments. To date, the HUS Hematology Laboratory does not have or is aware of any alternative method to overcome this interference, and is unable to perform anti-Xa activity when the sample has excessive lipemia. This study will evaluate, on samples from routine care artificially overloaded with lipids, the effectiveness of a high-speed centrifugation process (10,800g for 10 minutes).

Conditions

Hypertriglyceridemia

Keywords

Hypertriglyceridemia; High-Speed Centrifugation; Anti-Xa Activity; Lipemic Plasma; Hemostasis; Hematology

Outcome Measures

Primary Outcomes (1)

• To determine whether high-speed centrifugation (10,800g for 10 minutes) effectively separates the lipid fraction from the rest of the plasma

  To determine whether high-speed centrifugation (10,800g for 10 minutes) effectively separates the lipid fraction from the rest of the plasma, in order to measure anti-Xa activity, and to ensure that this process does not interfere with this measurement.

  Up to 10 minutes

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patient (≥ 18 years) anticoagulated with an anti-Xa

You may qualify if:

• Adult patient (≥ 18 years)
• Patient anticoagulated with an anti-Xa (UFH, LMWH, fondaparinux, danaparoid, apixaban, rivaroxaban)
• Sample sent to the HUS Hematology Laboratory and analyzed for measurement of the anti-Xa activity of an anticoagulant as part of routine care

You may not qualify if:

• Patient with a basal lipidemic sample
• Sample of insufficient volume

Sponsors & Collaborators

• University Hospital, Strasbourg, France: lead

Study Sites (1)

Laboratoire d'Hématologie - Unité d'Hémostase - CHU de Strasbourg - France

Strasbourg, 67091, France

RECRUITING

MeSH Terms

Conditions

Hypertriglyceridemia

Condition Hierarchy (Ancestors)

Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Central Study Contacts

Agathe HERB, PharmD

CONTACT

33 3 88 12 75 53; agathe.herb@chru-strasbourg.fr

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 26, 2025
• First Posted: October 1, 2025
• Study Start: March 11, 2024
• Primary Completion: December 11, 2025
• Study Completion: December 11, 2025
• Last Updated: October 1, 2025

Record last verified: 2025-03

Locations

FR (1)