Performance Evaluation of the Biological Diagnosis of HIT (HIT)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Heparin-induced Thrombocytopenia (HIT)

• Study Type: Observational
• Enrollment (Estimated): 894

Contacts and Locations

• Study Contact: Name: Agathe HERB, PharmD; Phone Number: 33 3 88 12 75 53; Email: agathe.herb@chru-strasbourg.fr

Study Locations

• France
  • Strasbourg, France, 67091
    • Recruiting
    • Laboratoire d'Hématologie - CHU de Strasbourg - France
    • Contact: Agathe HERB, PharmD; Phone Number: 33 3 88 12 75 53; Email: agathe.herb@chru-strasbourg.fr
    • Principal Investigator: Agathe HERB, PharmD
    • Sub-Investigator: Mathilde DEPIERREUX, PharmD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: University Hospital, Strasbourg, France

Study record dates

Study Major Dates

• Study Start (Actual): June 27, 2022
• Primary Completion (Estimated): December 1, 2023
• Study Completion (Estimated): December 1, 2023

Study Registration Dates

• First Submitted: September 6, 2022
• First Submitted That Met QC Criteria: December 12, 2023
• First Posted (Actual): December 22, 2023

Study Record Updates

• Last Update Posted (Actual): December 22, 2023
• Last Update Submitted That Met QC Criteria: December 12, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: HIT; Heparin-induced thrombocytopenia; IgG antibodies; heparin therapy; heparin treatments; molecular weight heparin; platelet factor 4 (PF4); heparin complex; thrombotic risk
• Additional Relevant MeSH Terms: Hematologic Diseases; Blood Platelet Disorders; Thrombocytopenia
• Other Study ID Numbers: 8665 (Fred Hutch/University of Washington Cancer Consortium)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No