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NCT Number: NCT06033300

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

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU Amiens

Amiens, 80480, France

Location status: Recruiting

Location contact

ABOU ARAB Osama, Pr

SUB_INVESTIGATOR

BASILE Damien, MD

SUB_INVESTIGATOR

CANAPLE Sandrine, MD

SUB_INVESTIGATOR

Choukroun Gabriel, Pr

SUB_INVESTIGATOR

HAYE Guillaume, MD

SUB_INVESTIGATOR

HERMIDA Alexis, MD

SUB_INVESTIGATOR

MALAQUIN Stéphanie, MD

SUB_INVESTIGATOR

Maïlys LE GUYADER, MD

CONTACT

[email protected]

03.22.08.70.00

SALLE Valery, MD

SUB_INVESTIGATOR

SOUDET Simon, MD

SUB_INVESTIGATOR

Schmidt Jean, MD

SUB_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Blood sample

Biological

blood sample

Primary outcomes

  1. percentage of CD41a+/CD45- platelet clusters

    Time frame: day 1

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

Study contacts

Contact information is provided by the study sponsor or research team.

LE GUYADER MAILYS, MD

CONTACT

[email protected]

03.22.08.70.40

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire, Amiens

Other

Registry information

Acronym: HITSTREAM

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Sep 13, 2023
Registry last updated
May 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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