Argatroban Monitoring in Acute Suspected Heparin-induced Thrombocytopenia.

NCT06066762 | Unknown

• 1 other identifier: APHP231085
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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

Keywords

thrombocytopenia; argatroban; fibrin monomers

Outcome Measures

Primary Outcomes (1)

• Adaptation of the argatroban dose on FM (fibrin monomers) to allow better dose adjustment of Argatroban in patients with suspected HIT

  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.

  12 days

Secondary Outcomes (1)

• Determine the therapeutic zone for argatroban, which is not clearly defined to date, based on the following main criteria: FM negativation, correction of thrombocytopenia, absence of thrombotic and hemorrhagic events.

  12 days

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patient with suspected heparin-induced thrombocytopenia and for whom Argatroban is prescribed as part of the treatment.

You may qualify if:

• patients suspected of having HIT in any department, including ECMO in the 10 centers
• patient starting a treatment with argatroban.
• major patients

You may not qualify if:

• Minor patients
• Patient under legal protection (guardianship or curatorship)
• Patient objecting to re-use of data and samples

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Hopital Bichat-Claude Bernard

Paris, 75018, France

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

* Nature of samples: plasma from a tube of citrated blood * Quantity/volume of samples taken: between 3 and 5 ml per collection time and according to the practice of the participating centres * Quantity/volume of samples kept for research purposes: between 2 to 3 plasma aliquots of 400 μl / patient corresponding to the samples taken as part of the care and during the follow-up of the participant - Storage conditions: - 80°C * Identification of aliquots: registration of the unique and project-specific identification number + Acronym of the project

MeSH Terms

Conditions

Thrombocytopenia

Condition Hierarchy (Ancestors)

Blood Platelet Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Cytopenia

Study Officials

• Nadine Ajzenberg, MD, PhD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nadine Ajzenberg, MD, PhD

CONTACT

01 40 25 62 73; nadine.ajzenberg@aphp.fr

Dorothée Faille, MD

CONTACT

dorothee.faille@aphp.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 28, 2023
• First Posted: October 4, 2023
• Study Start: November 1, 2023
• Primary Completion: May 1, 2025
• Study Completion: June 1, 2025
• Last Updated: October 4, 2023

Record last verified: 2023-09

Locations

FR (1)