Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07302620

HEPARINS: INTERFERENCE IN ARGATROBAN MEASUREMENT

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Strasbourg, 67091, France

Location status: Recruiting

Location contact

Agathe HERB, PharmD

CONTACT

[email protected]

33 3 88 12 75 53

Agathe HERB, PharmD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

s:

  • 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

Treatment and study plan

Primary outcomes

  1. Pearson or Spearman correlation test

    Time frame: 1 hour after analysis

    • 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Agathe HERB, PharmD

CONTACT

[email protected]

33 3 88 12 75 53

Sponsors and collaborators

Lead sponsor

University Hospital, Strasbourg, France

Other

Registry information

Acronym: HIMA

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Dec 24, 2025
Registry last updated
Dec 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.