Performance Evaluation of the Biological Diagnosis of HIT

NCT06180785 | Unknown

• 1 other identifier: 8665
• Study Type: observational
• Target: 894
• Locations: 1 country
• Sites: 1

Brief Summary

Heparin-induced thrombocytopenia (HIT) is a severe complication of heparin therapy with a non-negligible incidence (estimated at 2.6% of unfractionated heparin treatments and 0.2% of low molecular weight heparin treatments). It is generally secondary to the appearance of IgG antibodies directed against the platelet factor 4 (PF4) - heparin complex. These antibodies, once bound to this complex, are likely to activate platelets: the thrombotic risk generated can be potentially fatal.

Conditions

Heparin-induced Thrombocytopenia (HIT)

Keywords

Heparin-induced thrombocytopenia; HIT; heparin therapy; heparin treatments; molecular weight heparin; IgG antibodies; platelet factor 4 (PF4); heparin complex; thrombotic risk

Outcome Measures

Primary Outcomes (1)

• Retrospective description of the biological diagnosis approach for heparin-induced thrombocytopenia (HIT) in the Hematology laboratory of the University Hospitals of Strasbourg

  through study completion, an average of 1 month

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patient (≥ 18 years of age) hospitalized at HUS between 01/01/2009 and 31/12/2019

You may qualify if:

• Adult patient (≥ 18 years of age)
• Hospitalized at HUS between 01/01/2009 and 31/12/2019
• Specimen sent to the HUS Hematology Laboratory for biological diagnosis of HIT between 01/01/2009 and 31/12/2019
• Data collected by the CRPV and analyzed by the HIT multidisciplinary group in order to reach a consensus decision on the presence or absence of HIT
• Patient does not object to the reuse of his medical data for scientific research purposes.

You may not qualify if:

• Patient for whom no test has been performed at the HUS Hematology Laboratory
• Patient for whom no data has been collected by the CRPV
• Patient for whom the HIT group could not confirm or deny the presence of HIT

Sponsors & Collaborators

• University Hospital, Strasbourg, France: lead

Study Sites (1)

Laboratoire d'Hématologie - CHU de Strasbourg - France

Strasbourg, 67091, France

RECRUITING

Central Study Contacts

Agathe HERB, PharmD

CONTACT

33 3 88 12 75 53; agathe.herb@chru-strasbourg.fr

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 6, 2022
• First Posted: December 22, 2023
• Study Start: June 27, 2022
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: December 22, 2023

Record last verified: 2023-12

Locations

FR (1)