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HEPARINS: INTERFERENCE IN ARGATROBAN MEASUREMENT

NCT ID: NCT07302620

Last Updated: 2025-12-24

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

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Recruitment Status

RECRUITING

Total Enrollment

70 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-12-03

Study Completion Date

2026-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Thromboembolic Disease

Keywords

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

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* Patient receiving an anticoagulant other than UFH or LMWH
* Insufficient sample volume
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Strasbourg, France

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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

Strasbourg, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Agathe HERB, PharmD

Role: CONTACT

Phone: 33 3 88 12 75 53

Email: [email protected]

Facility Contacts

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Agathe HERB, PharmD

Role: primary

Other Identifiers

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9457

Identifier Type: -

Identifier Source: org_study_id