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Clinical Trials/NCT06257290
NCT06257290
Recruiting
Not Applicable

The Role of Platelet TLRs in Platelet Activation During VTE

Centre Hospitalier Universitaire de Saint Etienne1 site in 1 country100 target enrollmentStarted: October 11, 2023Last updated:

Overview

Phase
Not Applicable
Status
Recruiting
Enrollment
100
Locations
1
Primary Endpoint
expression of TLR2/ TRL4

Overview

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.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

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

Intervention: blood sample (Biological)

Outcomes

Primary Outcomes

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).

Secondary Outcomes

  • Analysis of characteristic soluble profile of the inflammatory role of platelets(at day1 and at 6 months)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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