Characterization and Quantification of Platelet/Leukocyte Aggregates in Patients With Suspected Heparin-induced Thrombocytopenia (HITSTREAM)
Primary Purpose
Heparin-induced Thrombocytopenia, HIT, Platelet Activation
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
blood sample
Sponsored by
About this trial
This is an interventional other trial for Heparin-induced Thrombocytopenia focused on measuring Heparin-induced Thrombocytopenia
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
Sites / Locations
- CHU AmiensRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
suspected heparin-induced thrombocytopenia:
Arm Description
Outcomes
Primary Outcome Measures
percentage of CD41a+/CD45- platelet clusters
percentage of CD41a+/CD45- platelet clusters relative to platelet count by Flow Imaging ImageStream
Secondary Outcome Measures
Full Information
NCT ID
NCT06033300
First Posted
September 5, 2023
Last Updated
September 12, 2023
Sponsor
Centre Hospitalier Universitaire, Amiens
1. Study Identification
Unique Protocol Identification Number
NCT06033300
Brief Title
Characterization and Quantification of Platelet/Leukocyte Aggregates in Patients With Suspected Heparin-induced Thrombocytopenia
Acronym
HITSTREAM
Official Title
Characterization and Quantification of Platelet/Leukocyte Aggregates in Patients With Suspected Heparin-induced Thrombocytopenia
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 17, 2023 (Actual)
Primary Completion Date
April 2026 (Anticipated)
Study Completion Date
April 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire, Amiens
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heparin-induced Thrombocytopenia, HIT, Platelet Activation, Platelets, Leukocytes, Platelet/Leukocyte Aggregates, HITSTREAM, Flow Cytometry
Keywords
Heparin-induced Thrombocytopenia
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
suspected heparin-induced thrombocytopenia:
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
blood sample
Intervention Description
blood sample
Primary Outcome Measure Information:
Title
percentage of CD41a+/CD45- platelet clusters
Description
percentage of CD41a+/CD45- platelet clusters relative to platelet count by Flow Imaging ImageStream
Time Frame
day 1
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
LE GUYADER MAILYS, MD
Phone
03.22.08.70.40
Email
leguyader.mailys@chu-amiens.fr
Facility Information:
Facility Name
CHU Amiens
City
Amiens
ZIP/Postal Code
80480
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maïlys LE GUYADER, MD
Phone
03.22.08.70.00
Email
leguyader.mailys@chu-amiens.fr
First Name & Middle Initial & Last Name & Degree
ABOU ARAB Osama, Pr
First Name & Middle Initial & Last Name & Degree
HAYE Guillaume, MD
First Name & Middle Initial & Last Name & Degree
SALLE Valery, MD
First Name & Middle Initial & Last Name & Degree
CANAPLE Sandrine, MD
First Name & Middle Initial & Last Name & Degree
BASILE Damien, MD
First Name & Middle Initial & Last Name & Degree
Schmidt Jean, MD
First Name & Middle Initial & Last Name & Degree
MALAQUIN Stéphanie, MD
First Name & Middle Initial & Last Name & Degree
SOUDET Simon, MD
First Name & Middle Initial & Last Name & Degree
HERMIDA Alexis, MD
First Name & Middle Initial & Last Name & Degree
Choukroun Gabriel, Pr
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Characterization and Quantification of Platelet/Leukocyte Aggregates in Patients With Suspected Heparin-induced Thrombocytopenia
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