NCT07302620 HEPARINS: INTERFERENCE IN ARGATROBAN MEASUREMENT
| NCT ID | NCT07302620 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital, Strasbourg, France |
| Condition | Thromboembolic Disease |
| Study Type | OBSERVATIONAL |
| Enrollment | 70 participants |
| Start Date | 2024-12-03 |
| Primary Completion | 2026-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 70 participants in total. It began in 2024-12-03 with a primary completion date of 2026-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07302620 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Thromboembolic Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07302620 currently recruiting?
Yes, NCT07302620 is actively recruiting participants. Contact the research team at agathe.herb@chru-strasbourg.fr for enrollment information.
Where is the NCT07302620 trial being conducted?
This trial is being conducted at Strasbourg, France.
Who is sponsoring the NCT07302620 clinical trial?
NCT07302620 is sponsored by University Hospital, Strasbourg, France. The trial plans to enroll 70 participants.