HEPARINS: INTERFERENCE IN ARGATROBAN MEASUREMENT

NCT07302620 | Recruiting

• 1 other identifier: 9457
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

Unfractionated heparin (UFH) and low molecular weight heparins (LMWH) provide anticoagulation through their anti-Xa and anti-IIa activity. This anti-IIa activity can lead to an overestimation of argatroban's activity when switching to an anti-IIa anticoagulant such as argatroban. This situation can be critical because argatroban is generally administered following heparin therapy due to suspected heparin-induced thrombocytopenia. Therefore, there is both a significant thrombotic risk induced by the underlying condition and a hemorrhagic risk induced by the anticoagulation. For this reason, it is important to be able to accurately monitor the anti-IIa activity of argatroban. To date, the test used to determine the anti-IIa activity of argatroban at the Hematology Laboratory of the Strasbourg University Hospitals (HUS) is a modified thrombin time (with a calibration curve adapted for argatroban). When switching between several molecules with anti-IIa activity, this test does not allow for the differentiation of the anti-IIa activity attributable to each anticoagulant. There are no data in the literature to determine whether heparins interfere with this test, and if so, its extent.

Conditions

Thromboembolic Disease

Keywords

Thromboembolic Disease; HEPARINS; ARGATROBAN; Unfractionated heparin (UFH); Low molecular weight heparins (LMWH); Anti-Xa and anti-IIa activity

Outcome Measures

Primary Outcomes (1)

• Pearson or Spearman correlation test

  * A correlation test (Spearman or Pearson) will be performed to compare anti-Xa activity with anti-IIa activity to determine if there is a significant correlation that could lead to an overestimation of argatroban's anti-IIa activity during a heparin-argatroban switch. * Spearman correlation uses the rank of the data to measure monotonicity between ordinal or continuous variables. Pearson correlation, on the other hand, detects linear relationships between quantitative variables with data following a normal distribution.

  1 hour after analysis

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 UFH or LMWH

You may qualify if:

• Adult patient (≥ 18 years)
• Patient anticoagulated with UFH or LMWH
• Sample sent to the Hematology Laboratory of the University Hospitals of Strasbourg (HUS) and analyzed for measurement of the anti-Xa activity of an anticoagulant in routine care

You may not qualify if:

• Patient receiving an anticoagulant other than UFH or LMWH
• Insufficient sample 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

Thromboembolism

Condition Hierarchy (Ancestors)

Embolism and Thrombosis; Vascular Diseases; Cardiovascular 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: December 10, 2025
• First Posted: December 24, 2025
• Study Start: December 3, 2024
• Primary Completion: January 1, 2026
• Study Completion: January 1, 2026
• Last Updated: December 24, 2025

Record last verified: 2025-12

Locations

FR (1)