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HEPARINS: INTERFERENCE IN ARGATROBAN MEASUREMENT (HIMA)

U

University Hospital, Strasbourg, France

Status

Enrolling

Conditions

Thromboembolic Disease

Study type

Observational

Funder types

Other

Identifiers

NCT07302620
9457 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment

70 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criterias:

  • 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

Trial contacts and locations

1

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Central trial contact

Agathe HERB, PharmD

Data sourced from clinicaltrials.gov

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