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

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06033300
Acronym
HITSTREAM
Enrollment
200
Registered
2023-09-13
Start date
2023-04-17
Completion date
2026-04-30
Last updated
2025-05-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Heparin-induced Thrombocytopenia

Brief summary

The investigators would like to analyze platelet/leukoplak activation, quantify and morphologically characterize these aggregates using in vitro analysis, directly on whole blood from adult patients with suspected HIT. This would enable to better describe the in vivo pathophysiology of the HIT-suspect patient, and eliminate the need for platelet donors to perform the usual confirmatory techniques, whose inter- and intra-individual variability is very high. What's more, the SRA test, evaluated as the reference test, requires the use of radioisotopes and is therefore only carried out in a few biological expertise centers, resulting in a very long delay in the delivery of results. It should also be noted that, in practice, HÉPARINE is immediately stopped in patients with suspected HIT, and they are put on an expensive anticoagulant (DANAPAROIDE SODIQUE or ARGATROBAN) in curative doses until the results of the confirmatory tests are back. In this serious, life-threatening condition, it is essential to have a sensitive, specific test to confirm HIT as quickly as possible. Each patient with suspected HIT (rapid \>30% reduction in platelet count after initiation of heparin therapy) should have 4 tubes of 3.2% citrated whole blood (2.7ml) collected at the time of suspected HIT (D0) and before any therapeutic switch (or 24 h max after switch). A new sample (4 citrated tubes) will be taken at D4, D7 and D14 during hospitalization, in patients who test positive for anti-PF4/H Ac. All patients with suspected HIT will follow the standard diagnostic pathway, i.e. a screening test (immunological test for anti-PF4/heparin antibodies, total Ig, ACL TOP, Werfen) followed by a confirmatory test (platelet aggregation on TA-8V, STAGO and/or SRA). Doppler ultrasonography of the lower limbs will be performed in HIT-suspect patients with a positive anti-PF4/H antibody test, as currently performed as part of routine care.

Interventions

BIOLOGICALblood sample

blood sample

Sponsors

Centre Hospitalier Universitaire, Amiens
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
percentage of CD41a+/CD45- platelet clustersday 1percentage of CD41a+/CD45- platelet clusters relative to platelet count by Flow Imaging ImageStream

Countries

France

Contacts

Primary ContactLE GUYADER MAILYS, MD
leguyader.mailys@chu-amiens.fr03.22.08.70.40

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026