Platelet DisorderPLATELETSTREAMNCT04842760
PLATELET Function Assay With Flow Imaging on ImageSTREAM Cytometer
An observational study of Platelet Disorder and Heparin-induced Thrombocytopenia, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
Trial summary
Platelets are essential blood elements to maintain hemostasis. Quantitative or qualitative defects can be responsible of hemorrhagic (platelet disorders) or thrombotic (heparin induced thrombocytopenia [HIT]) troubles. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Platelet Disorder, Heparin-induced Thrombocytopenia, Platelet Activation
- How many people
- 31 participants
- Where
- 1 siteFrance
- Study dates
- 1 Mar 2021to 15 Oct 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Male or female patient for whom a blood test was prescribed in a context of diagnosis of platelet dysfunction or HIT.
Who may be able to join
- male or female patient for whom a blood test was prescribed in a context of diagnosis of platelet dysfunction or HIT
Who cannot join
- minor patients
- patients who have opposed the use of their personal data for research work.
Trial locations and contacts
1 site in 1 country.
About this study
Platelets are essential blood elements to maintain hemostasis. Quantitative or qualitative defects can be responsible of hemorrhagic (platelet disorders) or thrombotic (heparin induced thrombocytopenia [HIT]) troubles. Diagnosis of these pathologies is sometimes urgent and consists in delicate platelet functional assays that are mostly made in expert centers. These platelets functional assays measure platelets activation and/or aggregation in response to diverse inductors and may lack sensitivity. The investigators would like to propose a new diagnostic tool with the use of imaging flow cytometry which provides much more information than classic cytometer on cell morphology thanks to images collected by the optical channel of the ImageStream cytometer. The use of this cytometer offers an innovative approach.
This study is a monocentric prospective and non-interventional study. The investigators will analyze patient samples with the ImageStream cytometer and reference laboratory tests (light transmission aggregometry and serotonin release assay) in parallel and compare results from the different techniques. This new diagnostic technique will demonstrate a non-inferiority diagnosis compared to reference tests and maybe a better sensibility.
- Conditions
- Platelet Disorder, Heparin-induced Thrombocytopenia, Platelet Activation, Platelet Aggregation
- Keywords
- Platelet Disorder, Heparin-induced Thrombocytopenia, ImageStream cytometer, Platelet activation, Platelet aggregation
- Medical subject headings
- Blood Platelet Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| No platelet disorders or no HIT | Patients without platelet disorders or without HIT, without anti-PF4/H antibodies, without anti-aggregant treatment. | |
| HIT patients with anti-PF4/H antibodies | patients with anti-PF4/H antibodies but for whom HIT was ruled out. | |
| platelet dysfunction or HIT | Patients with platelet dysfunction or suffering from HIT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concordance between ImageStream cytometer and reference laboratory tests for platelet disorders diagnosis
platelet disorders reference laboratory tests are light transmission aggregometry and serotonin release assay
Measured: 12 months
Concordance between ImageStream cytometer and reference laboratory tests for HIT diagnosis
reference laboratory tests are light transmission aggregometry and serotonin release assay
Measured: 12 months
Secondary outcomes (1)
Characterization of platelet morphology with ImageStream
Analyses of data provided by the ImageStream system on platelets and platelets aggregates
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2021
- Study start1 Mar 2021
- Primary completion15 Oct 2021
- Study completion15 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Platelet DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04842760
- Sponsor's protocol ID
- PI2021_843_0039
- Acronym
- PLATELETSTREAM
- Status last verified
- Jun 2026
- First submitted
- 7 Apr 2021
- Last updated
- 12 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PLATELET Function Assay With Flow Imaging on ImageSTREAM Cytometer
- ClinicalTrials.gov ID
- NCT04842760
- Acronym / sponsor ID
- PLATELETSTREAM / PI2021_843_0039
- Conditions
- Platelet Disorder, Heparin-induced Thrombocytopenia, Platelet Activation, Platelet Aggregation
- Keywords
- Platelet Disorder, Heparin-induced Thrombocytopenia, ImageStream cytometer, Platelet activation, Platelet aggregation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 15 Oct 2021 (actual)
- Study completion
- 15 Oct 2021 (actual)
- First posted
- 13 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Platelets are essential blood elements to maintain hemostasis. Quantitative or qualitative defects can be responsible of hemorrhagic (platelet disorders) or thrombotic (heparin induced thrombocytopenia [HIT]) troubles. Diagnosis of these pathologies is sometimes urgent and consists in delicate platelet functional assays that are mostly made in expert centers. These platelets functional assays measure platelets activation and/or aggregation in response to diverse inductors and may lack sensitivity. The investigators would like to propose a new diagnostic tool with the use of imaging flow cytometry which provides much more information than classic cytometer on cell morphology thanks to images collected by the optical channel of the ImageStream cytometer. The use of this cytometer offers an innovative approach.
This study is a monocentric prospective and non-interventional study. The investigators will analyze patient samples with the ImageStream cytometer and reference laboratory tests (light transmission aggregometry and serotonin release assay) in parallel and compare results from the different techniques. This new diagnostic technique will demonstrate a non-inferiority diagnosis compared to reference tests and maybe a better sensibility.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| No platelet disorders or no HIT | – | –Patients without platelet disorders or without HIT, without anti-PF4/H antibodies, without anti-aggregant treatment. |
| HIT patients with anti-PF4/H antibodies | – | –patients with anti-PF4/H antibodies but for whom HIT was ruled out. |
| platelet dysfunction or HIT | – | –Patients with platelet dysfunction or suffering from HIT |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Male or female patient for whom a blood test was prescribed in a context of diagnosis of platelet dysfunction or HIT.
Key inclusion criteria (1 listed)
- male or female patient for whom a blood test was prescribed in a context of diagnosis of platelet dysfunction or HIT
Key exclusion criteria (2 listed)
- minor patients
- patients who have opposed the use of their personal data for research work.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Concordance between ImageStream cytometer and reference laboratory tests for platelet disorders diagnosis
Time frame: 12 months
platelet disorders reference laboratory tests are light transmission aggregometry and serotonin release assay
Concordance between ImageStream cytometer and reference laboratory tests for HIT diagnosis
Time frame: 12 months
reference laboratory tests are light transmission aggregometry and serotonin release assay
1 secondary outcome
Characterization of platelet morphology with ImageStream
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Platelet Disorder and Heparin-induced Thrombocytopenia, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Concordance between ImageStream cytometer and reference laboratory tests for platelet disorders diagnosis (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2026.