Performance Evaluation of the Biological Diagnosis of HIT

Heparin-induced Thrombocytopenia (HIT) Clinical Trial

— HIT  

Official title:

Performance Evaluation of the Biological Diagnosis of Heparin-induced Thrombocytopenia (HIT)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06180785
• Other study ID #: 8665
• Status: Recruiting
• Start date: June 27, 2022
• Est. completion date: December 2023

Study information

• Verified date: December 2023
• Source: University Hospital, Strasbourg, France
• Contact: Agathe HERB, PharmD
• Phone: 33 3 88 12 75 53
• Email: agathe.herb[@]chru-strasbourg.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 894
• Est. completion date: December 2023
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion criteria :

• 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.

Exclusion criteria:

• 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

Related Conditions & MeSH terms

• Heparin-induced Thrombocytopenia (HIT)
• Thrombocytopenia

Locations

Country	Name	City	State
France	Laboratoire d'Hématologie - CHU de Strasbourg - France	Strasbourg

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Strasbourg, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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