Evaluating the biological diagnosis of Heparin-induced Thrombocytopenia
Performance Evaluation of the Biological Diagnosis of Heparin-induced Thrombocytopenia (HIT)
This study is testing a new way to diagnose Heparin-induced Thrombocytopenia by looking for specific antibodies in hospitalized adults to help improve how we identify this serious condition.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 894 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Strasbourg, France Academic / other |
| Locations | 1 site (Strasbourg) |
| Trial ID | NCT06180785 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on Heparin-induced Thrombocytopenia (HIT), a serious complication arising from heparin therapy. It aims to evaluate the performance of biological diagnostics for HIT by analyzing data collected from hospitalized adult patients at the University Hospital of Strasbourg over a ten-year period. The study will assess the presence of IgG antibodies against the platelet factor 4-heparin complex, which are responsible for the thrombotic risks associated with HIT. The findings will be analyzed by a multidisciplinary group to reach a consensus on the diagnosis of HIT.
Who should consider this trial
Good fit: Ideal candidates for this study are hospitalized adults aged 18 and older who had specimens sent for biological diagnosis of HIT during the specified timeframe.
Not a fit: Patients who did not have tests performed at the HUS Hematology Laboratory or for whom the HIT diagnosis could not be confirmed will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve the accuracy of diagnosing HIT, leading to better management and outcomes for affected patients.
How similar studies have performed: While the specific approach of this study may be novel, previous studies have indicated the importance of accurate biological diagnosis in managing HIT effectively.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Strasbourg
- Laboratoire d'Hématologie - CHU de Strasbourg - France — Strasbourg, France (Recruiting)
Study contacts
- Study coordinator: Agathe HERB, PharmD
- Email: agathe.herb@chru-strasbourg.fr
- Phone: 33 3 88 12 75 53
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.