The Role of Platelet TLRs in Platelet Activation During VTE

NCT06257290 | Terminated

• 2 other identifiers: 22CH4002023-A00448-37
• Study Type: observational
• Target: 44
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Venous Thromboembolism

Keywords

venous thromboembolism; VTE; sequelae; immunothrombosis; platelets; inflammatory receptors

Outcome Measures

Primary Outcomes (1)

• 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. 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).

  at day1 and at 6 months

Secondary Outcomes (1)

• Analysis of characteristic soluble profile of the inflammatory role of platelets

  at day1 and at 6 months

Study Arms (1)

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

Biological: blood sample

Interventions

blood sample BIOLOGICAL

at Day 1 - date of patient inclusion at time of VTE diagnosis

Venous ThromboEmbolic (VTE) patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Venous ThromboEmbolic (VTE) patients

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Saint Etienne: lead

Study Sites (1)

Chu St-Etienne

Saint-Etienne, 42055, France

Location

Biospecimen

Retention: SAMPLES WITH DNA

quantification of TLR2/TLR4 receptor expression by flow cytometry

MeSH Terms

Conditions

Venous Thromboembolism; Thromboinflammation

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Thromboembolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Thrombosis; Blood Coagulation Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2024
• First Posted: February 13, 2024
• Study Start: October 11, 2023
• Primary Completion: April 9, 2025
• Study Completion: October 10, 2025
• Last Updated: May 8, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)