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

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.

Study Overview

• Status: Recruiting
• Conditions: Heparin-induced Thrombocytopenia; Platelet Activation; Platelets; Leukocytes; HIT; Platelet/Leukocyte Aggregates; HITSTREAM; Flow Cytometry
• Intervention / Treatment: Biological: blood sample

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: LE GUYADER MAILYS, MD; Phone Number: 03.22.08.70.40; Email: leguyader.mailys@chu-amiens.fr

Study Locations

• France
  • Amiens, France, 80480
    • Recruiting
    • CHU Amiens
    • Contact: Maïlys LE GUYADER, MD; Phone Number: 03.22.08.70.00; Email: leguyader.mailys@chu-amiens.fr
    • Sub-Investigator: ABOU ARAB Osama, Pr
    • Sub-Investigator: HAYE Guillaume, MD
    • Sub-Investigator: SALLE Valery, MD
    • Sub-Investigator: CANAPLE Sandrine, MD
    • Sub-Investigator: BASILE Damien, MD
    • Sub-Investigator: Schmidt Jean, MD
    • Sub-Investigator: MALAQUIN Stéphanie, MD
    • Sub-Investigator: SOUDET Simon, MD
    • Sub-Investigator: HERMIDA Alexis, MD
    • Sub-Investigator: Choukroun Gabriel, Pr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: suspected heparin-induced thrombocytopenia:	Biological: blood sample; blood sample

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
percentage of CD41a+/CD45- platelet clusters	percentage of CD41a+/CD45- platelet clusters relative to platelet count by Flow Imaging ImageStream	day 1

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire, Amiens

Study record dates

Study Major Dates

• Study Start (Actual): April 17, 2023
• Primary Completion (Estimated): April 1, 2026
• Study Completion (Estimated): April 1, 2026

Study Registration Dates

• First Submitted: September 5, 2023
• First Submitted That Met QC Criteria: September 5, 2023
• First Posted (Actual): September 13, 2023

Study Record Updates

• Last Update Posted (Actual): September 14, 2023
• Last Update Submitted That Met QC Criteria: September 12, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Heparin-induced Thrombocytopenia
• Additional Relevant MeSH Terms: Hematologic Diseases; Blood Platelet Disorders; Thrombocytopenia
• Other Study ID Numbers: PI2023_843_0047

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No