Venous ThromboembolismROT-PLAT-VTENCT06257290
The Role of Platelet TLRs in Platelet Activation During VTE
An observational study of Venous Thromboembolism, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
Trial summary
Venous thromboembolic disease (VTE) is a frequent and potentially serious pathology. Therapeutic management has improved considerably over the last few decades, enabling the application of codified management in line with the recently updated French management recommendations. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Venous Thromboembolism
- What is being tested?
- blood sample
- How many people
- 44 participants
- Where
- 1 siteFrance
- Study dates
- 11 Oct 2023to 10 Oct 2025
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Venous ThromboEmbolic (VTE) patients
Who may be able to join
- Patients diagnosed with Venous ThromboEmbolic (VTE) / Proximal Deep vein thrombosis (DVT) of the lower limb and/or pulmonary embolism ≤ 72heures
- Patients are 18 years of age or older at diagnosis.
- Patients received informed written consent
- Patients benefiting from social security coverage
Who cannot join
- Diagnosis of Venous ThromboEmbolic (VTE) more than 72 hours old
- Isolated sub-segmental pulmonary embolism
- Patients on antiplatelet agents
- Patients on non-steroidal anti-inflammatory drugs (NSAIDs)
- Life expectancy > 3 months
Trial locations and contacts
1 site in 1 country.
About this study
Venous thromboembolic disease (VTE) is a frequent and potentially serious pathology. Therapeutic management has improved considerably over the last few decades, enabling the application of codified management in line with the recently updated French management recommendations.
One of the main remaining difficulties concerns VTE sequelae, mainly post-thrombotic syndrome after deep vein thrombosis, and post-pulmonary embolism syndrome after pulmonary embolism. The mechanisms leading to the absence of complete repermeabilization of vessels affected by Venous thromboembolic disease (VTE) are still poorly understood.
Read more
The concept of immunothrombosis, closely associating immunity, inflammation and thrombosis, could (in part) explain the appearance of these sequelae. Platelets appear to play a key role in the onset of sequelae: Platelets are known to be involved both in the onset of a VTE episode and in the inflammatory response. This involvement is illustrated by the expression of inflammatory receptors such as TLR (toll-like receptor) 2 and TLR4.
Th aim to investigate the role of platelets in the occurrence of sequelae, mainly via their role in the inflammatory response, in Venous thromboembolic disease (VTE) patients.
- Conditions
- Venous Thromboembolism
- Being tested
- blood sample
- Keywords
- venous thromboembolism, VTE, sequelae, immunothrombosis, platelets, inflammatory receptors
- Medical subject headings
- Venous Thromboembolism, Thromboinflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood sampleBiological
at Day 1 - date of patient inclusion at time of VTE diagnosis
blood sampleBiological
at 6 months (in the patient follow-up)
| Study group | Role | What they receive |
|---|---|---|
| Venous ThromboEmbolic (VTE) patients | a diagnosis of Venous ThromboEmbolic (VTE) less than 72 hours old at inclusion, with a follow-up of 3 to 6 months Receives: Biological: blood sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
expression of TLR2/ TRL4
The characteristic membrane profile of the inflammatory role of platelets is quantified by TLR2/TLR4 receptors expression using flow cytometry.
This profile will be compared between patients with VTE sequelae (objectified during follow-up, and defined in accordance with good practice recommendations) 20,21 and patients without VTE sequelae.
- A patient with sequelae corresponds to patients who will present during follow-up with a post-thrombotic syndrome (defined by a Villalta score greater than or equal to 5) and/or a post-pulmonary post-pulmonary embolism syndrome (defined by NYHA stage II, III or IV dyspnea, and the presence of perfusion perfusion sequelae on lung scintigraphy).
Measured: at day1 and at 6 months
Secondary outcomes (1)
Analysis of characteristic soluble profile of the inflammatory role of platelets
The characteristic soluble profile of the inflammatory role of platelets associated with the existence of sequelae remote from the acute episode of VTE, is quantified by blood assay of platelet immunomodulatory factors (ELISA technique): soluble CD62P, HMGB1, RANTES, PF4, soluble CD40L
Measured: at day1 and at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2024
- Study start11 Oct 2023
- Primary completion9 Apr 2025
- Study completion10 Oct 2025
Why it stopped: Challenges in inclusion
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Venous ThromboembolismStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de Saint EtienneThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06257290
- Sponsor's protocol ID
- 22CH400
- Other IDs
- 2023-A00448-37
- Acronym
- ROT-PLAT-VTE
- Status last verified
- May 2026
- First submitted
- 6 Feb 2024
- Last updated
- 8 May 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 8 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Platelet TLRs in Platelet Activation During VTE
- ClinicalTrials.gov ID
- NCT06257290
- Acronym / sponsor ID
- ROT-PLAT-VTE / 22CH400
- Conditions
- Venous Thromboembolism
- Keywords
- venous thromboembolism, VTE, sequelae, immunothrombosis, platelets, inflammatory receptors
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Challenges in inclusion
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Study start
- 11 Oct 2023 (actual)
- Primary completion
- 9 Apr 2025 (actual)
- Study completion
- 10 Oct 2025 (actual)
- First posted
- 13 Feb 2024 (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.
Venous thromboembolic disease (VTE) is a frequent and potentially serious pathology. Therapeutic management has improved considerably over the last few decades, enabling the application of codified management in line with the recently updated French management recommendations.
One of the main remaining difficulties concerns VTE sequelae, mainly post-thrombotic syndrome after deep vein thrombosis, and post-pulmonary embolism syndrome after pulmonary embolism. The mechanisms leading to the absence of complete repermeabilization of vessels affected by Venous thromboembolic disease (VTE) are still poorly understood.
The concept of immunothrombosis, closely associating immunity, inflammation and thrombosis, could (in part) explain the appearance of these sequelae. Platelets appear to play a key role in the onset of sequelae: Platelets are known to be involved both in the onset of a VTE episode and in the inflammatory response. This involvement is illustrated by the expression of inflammatory receptors such as TLR (toll-like receptor) 2 and TLR4.
Th aim to investigate the role of platelets in the occurrence of sequelae, mainly via their role in the inflammatory response, in Venous thromboembolic disease (VTE) patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Venous ThromboEmbolic (VTE) patients | – | Biological: blood samplea diagnosis of Venous ThromboEmbolic (VTE) less than 72 hours old at inclusion, with a follow-up of 3 to 6 months |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Venous ThromboEmbolic (VTE) patients
Key inclusion criteria (4 listed)
- Patients diagnosed with Venous ThromboEmbolic (VTE) / Proximal Deep vein thrombosis (DVT) of the lower limb and/or pulmonary embolism ≤ 72heures
- Patients are 18 years of age or older at diagnosis.
- Patients received informed written consent
- Patients benefiting from social security coverage
Key exclusion criteria (5 listed)
- Diagnosis of Venous ThromboEmbolic (VTE) more than 72 hours old
- Isolated sub-segmental pulmonary embolism
- Patients on antiplatelet agents
- Patients on non-steroidal anti-inflammatory drugs (NSAIDs)
- Life expectancy > 3 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| blood sampleat Day 1 - date of patient inclusion at time of VTE diagnosis | Biological | Venous ThromboEmbolic (VTE) patients |
| blood sampleat 6 months (in the patient follow-up) | Biological | Venous ThromboEmbolic (VTE) patients |
Primary outcome
expression of TLR2/ TRL4
Time frame: at day1 and at 6 months
The characteristic membrane profile of the inflammatory role of platelets is quantified by TLR2/TLR4 receptors expression using flow cytometry. This profile will be compared between patients with VTE sequelae (objectified during follow-up, and defined in accordance with good practice recommendations) 20,21 and patients without VTE sequelae. o A patient with sequelae corresponds to patients who will present during follow-up with a post-thrombotic syndrome (defined by a Villalta score greater than or equal to 5) and/or a post-pulmonary post-pulmonary embolism syndrome (defined by NYHA stage II, III or IV dyspnea, and the presence of perfusion perfusion sequelae on lung scintigraphy).
1 secondary outcome
Analysis of characteristic soluble profile of the inflammatory role of platelets
Time frame: at day1 and at 6 months
Results and safety
The study was stopped early (reason given: Challenges in inclusion). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2026.
- Individual participant dataSharing planned: No
Related trials for Venous Thromboembolism
RecruitingPhase 3
REGN7508 Versus Apixaban and Enoxaparin for Thromboprophylaxis After Total Knee Arthroplasty in Adults
Venous Thromboembolism (VTE)
RecruitingPhase 3
Treatment and Secondary Prevention of Venous Thromboembolism (VTE) in Adult Participants With Solid and Hematologic Cancers
Venous Thromboembolism (VTE)
RecruitingPhase 3
REGN7508 in Adult Participants for Prevention of Cancer-Associated Thrombosis
Cancer-Associated Thrombosis (CAT)
RecruitingPhase 3
REGN7508 Versus Acetylsalicylic Acid (ASA) for Venous Thromboprophylaxis After Total Knee Arthroplasty in Adult Participants
Symptomatic Venous Thromboembolism (VTE)
Recruiting
DEFIANCE: RCT of ClotTriever System Versus Anticoagulation In Deep Vein Thrombosis
Venous Thromboembolism, Deep Venous Thrombosis
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 Venous Thromboembolism, run by Centre Hospitalier Universitaire de Saint Etienne 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 4 inclusion and 5 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: stopped early, as of the sponsor's last update on 8 May 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 was stopped early (reason given: Challenges in inclusion). Results are not available in the source record.
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?
expression of TLR2/ TRL4 (time frame: at day1 and at 6 months). 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 8 May 2026.