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

Sponsor

Centre Hospitalier Universitaire, Amiens (Other)

Overall Status

Recruiting

CT.gov ID

NCT06033300

Collaborator

(none)

200

Enrollment

Location

Arm

35.5

Anticipated Duration (Months)

5.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Heparin-induced Thrombocytopenia HIT Platelet Activation Platelets Leukocytes Platelet/Leukocyte Aggregates HITSTREAM Flow Cytometry	Biological: blood sample	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

200 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

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

Actual Study Start Date :

Apr 17, 2023

Anticipated Primary Completion Date :

Apr 1, 2026

Anticipated Study Completion Date :

Apr 1, 2026

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: suspected heparin-induced thrombocytopenia:

Biological: blood sample

blood sample

Outcome Measures

Primary Outcome Measures

percentage of CD41a+/CD45- platelet clusters [day 1]
percentage of CD41a+/CD45- platelet clusters relative to platelet count by Flow Imaging ImageStream

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CHU Amiens	Amiens		France	80480

Sponsors and Collaborators

Centre Hospitalier Universitaire, Amiens

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Centre Hospitalier Universitaire, Amiens

ClinicalTrials.gov Identifier:

NCT06033300

Other Study ID Numbers:

PI2023_843_0047

First Posted:

Sep 13, 2023

Last Update Posted:

Sep 14, 2023

Last Verified:

Sep 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Centre Hospitalier Universitaire, Amiens

Heparin-induced Thrombocytopenia

Additional relevant MeSH terms:

Thrombocytopenia

Study Results

No Results Posted as of Sep 14, 2023