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Performance Evaluation of the Biological Diagnosis of HIT

NCT ID: NCT06180785

Last Updated: 2023-12-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

894 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-06-27

Study Completion Date

2023-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Heparin-induced Thrombocytopenia (HIT)

Keywords

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

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Strasbourg, France

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Laboratoire d'Hématologie - CHU de Strasbourg - France

Strasbourg, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Agathe HERB, PharmD

Role: CONTACT

Phone: 33 3 88 12 75 53

Email: [email protected]

Facility Contacts

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Agathe HERB, PharmD

Role: primary

Other Identifiers

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8665

Identifier Type: -

Identifier Source: org_study_id