The Role of Platelet TLRs in Platelet Activation During VTE

Venous Thromboembolism Clinical Trial

— ROT-PLAT-VTE  

Official title:

The Role of Platelet TLRs in Platelet Activation During VTE

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06257290
• Other study ID #: 22CH400
• Secondary ID: 2023-A00448-37
• Status: Recruiting
• Start date: October 11, 2023
• Est. completion date: June 2026

Study information

• Verified date: March 2024
• Source: Centre Hospitalier Universitaire de Saint Etienne
• Contact: Laurent BERTOLETTI, MD PhD
• Phone: 477829121
• Email: laurent.bertoletti[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: June 2026
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Thromboembolism
• Venous Thromboembolism

Intervention

Biological:
• blood sample
at Day 1 - date of patient inclusion at time of VTE diagnosis
• blood sample
at 6 months (in the patient follow-up)

Locations

Country	Name	City	State
France	Chu St-Etienne	Saint-Étienne

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Saint Etienne

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	at day1 and at 6 months