An observational study in Thromboembolic Disease, sponsored by University Hospital, Strasbourg, France. Recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-12-24.
Sponsored by University Hospital, Strasbourg, France · Observational
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.
288 studies on the registry are indexed under Thromboembolism; 42 are open to participants now.
This study's planned enrollment of 70 is below the median of 440 across 121 observational studies indexed under Thromboembolism.
Browse Thromboembolism studies →University Hospital, Strasbourg, France is the lead sponsor of 999 studies on the registry; 358 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Adult patient (≥ 18 years) anticoagulated with UFH or LMWH
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Exclusion Criteria:
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.
Time frame: 1 hour after analysis
Started Dec 2024 (actual). Primary completion is estimated for Jan 2026, 13 months after the start.
Of 46 observational studies under Thromboembolism, half reached primary completion within 39 months of starting (the median), counting those still running; a quarter within 24 and three quarters within 65. This study's planned 13 months is below that.
How these figures are worked out, and which studies are left out of them.
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University Hospital, Strasbourg, France →