Analyzing blood components in patients suspected of heparin-induced thrombocytopenia

Characterization and Quantification of Platelet/Leukocyte Aggregates in Patients With Suspected Heparin-induced Thrombocytopenia

This study is testing a new way to look at blood samples from patients suspected of having heparin-induced thrombocytopenia to see if it can help doctors diagnose the condition faster and more accurately.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 200 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Centre Hospitalier Universitaire, Amiens (other)
• Locations: 1 site (Amiens)
• Trial ID: NCT06033300 on ClinicalTrials.gov

What this trial studies

This study aims to analyze platelet and leukocyte activation in patients suspected of having heparin-induced thrombocytopenia (HIT) by quantifying and characterizing these aggregates using in vitro analysis on whole blood samples. The goal is to improve the understanding of the pathophysiology of HIT and reduce reliance on traditional confirmatory tests that have high variability and require specialized facilities. By eliminating the need for platelet donors and minimizing delays in results, this approach could enhance patient management in a serious condition where timely diagnosis is critical.

Who should consider this trial

Good fit: Ideal candidates for this study are adults over 18 years old who are suspected of having HIT and have tested positive for anti-PF4/H antibodies.

Not a fit: Patients with suspected HIT who test negative for anti-PF4/H antibodies will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to faster and more accurate diagnosis of heparin-induced thrombocytopenia, improving patient outcomes.

How similar studies have performed: While this approach is innovative, it builds on existing knowledge of platelet activation and HIT, but specific prior studies using this exact methodology have not been widely reported.

Eligibility criteria

Inclusion Criteria:

* Age \> 18 years
* Any adult patient suspected of having HIT, with a positive anti-PF4/H antibody test
* Patient signed consent to study participation
* Patient with social security coverage

Exclusion Criteria:

* All adult patients with suspected HIT and negative anti-PF4/H antibody test.
* Protected adults (guardianship, under curators) or deprived of liberty

Where this trial is running

Amiens

• CHU Amiens — Amiens, France (RECRUITING)

Study contacts

• Study coordinator: LE GUYADER MAILYS, MD

Conditions: Heparin-induced Thrombocytopenia, HIT, Platelet Activation, Platelets, Leukocytes, Platelet/Leukocyte Aggregates, HITSTREAM, Flow Cytometry