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Studies

Observational Not yet recruiting

NCT06066762 on ClinicalTrials.gov

Argatroban Monitoring in Acute Suspected Heparin-induced Thrombocytopenia.

Official title: Monitoring of Argatroban Anticoagulant Therapy in Patients With Acute Suspected Heparin-induced Thrombocytopenia: French Multicenter Study

  • Sponsor: Assistance Publique - Hôpitaux de Paris
  • Enrollment: 200 (Estimated)
  • Study start: 2023-11-01 (Estimated)
  • Primary completion: 2025-05-01 (Estimated)
  • Study completion: 2025-06-01 (Estimated)
  • Allocation: N/a
  • InterventionModel: N/a
  • Masking: None
  • PrimaryPurpose: Other

Brief Summary

Heparin-induced thrombocytopenia (HIT) is a rare but potentially serious complication of heparin therapy. , argatroban is the alternative anticoagulant of choice in patients with suspected HIT and renal impairment, high bleeding risk or risk of invasive surgery/gesture. Despite its increasing use in these fragile patients, methods for biological monitoring of argatroban's anticoagulant activity are heterogeneous, and neither the therapeutic zone nor the modalities for argatroban dosage adjustment are clearly defined, particularly in patients in the acute phase of thrombosis.

Soluble fibrin monomers (FM) indirectly reflect thrombin generation in vivo. This marker could thus represent a new strategy for monitoring the anticoagulant activity of argatroban. However, the effect of argatroban anticoagulation on FM levels remains unknown.

In a preliminary retrospective study carried out at Bichat hospital, we showed that FM levels could therefore be an early marker of the efficacy of argatroban treatment in patients with suspected HIT.In order to confirm these results, we will include patients with clinico-biological suspicion of HIT and receiving argatroban treatment.

Ten French laboratories will participate in this study. All plasmas collected will be from samples taken only in the context of care.

This prospective study will determine whether the daily monitoring of FM is beneficial for the management of patients treated with argatroban.

Conditions

  • Heparin-induced Thrombocytopenia

Primary Outcome Measures

  • Adaptation of the argatroban dose on FM (fibrin monomers) to allow better dose adjustment of Argatroban in patients with suspected HIT (12 days)
    The study will help determine whether this dose adjustment of Argatroban on FM allows an earlier rise of platelets as well as a decrease in thrombotic and/or hemorrhagic events compared to centers that do not use FM.

Countries

France

Locations and Investigators

  • Hopital Bichat-Claude Bernard, Paris, France
    • Nadine Ajzenberg, MD, PhD

Study Officials