Ignite Creation Date:
2024-05-06 @ 6:35 PM
Last Modification Date:
2024-10-26 @ 2:50 PM
Study NCT ID:
NCT05711173
Status:
RECRUITING
Last Update Posted:
2024-05-14
First Post:
2023-01-24
Brief Title:
Clonal Hematopoiesis and NETs Formation in Venous Thrombosis CLODETTE
Sponsor:
University Hospital Bordeaux
Organization:
University Hospital Bordeaux
Study Overview
Official Title:
Role of Clonal Hematopoiesis and NETs Formation in Unusual Venous Thrombosis CLODETTE
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CLODETTE
Brief Summary:
Thrombo-embolic venous diseases are represented by deep venous thrombosis andor pulmonary embolism In some patients with repeated thrombosis or occurrence of thrombosis in unusual sites the etiological workup remains negative which represents a problem for the management of the anticoagulant treatments Recently two factors have been identified as important in the physiopathology of hemostasis and coagulation the presence of clonal hematopoiesis of indetermined potential CHIP and the formation of neutrophil extracellular traps NETs In this study these two factors will be studied in patients with repeated venous thrombosis or thrombosis occurring in unusual site
Detailed Description:
It has recently been shown that some patients clonal have mutations at a low level in hematopoietic cells this phenomenon is named clonal hematopoiesis of indetermined potential CHIP and that the presence of a clonal hematopoiesis is associated with an increased cardiovascular risk However few data exist about the implication of CHIP in venous thrombosis Neutrophils extracellular traps are involved in the activation of hemostasis and coagulation Murine models have highlighted the crucial role of NETs in the physiopathology of venous thrombosis In patients studies have demonstrated that NETs markers were present in arteries lesions as coronary plaques However few studies have analyzed the NETosis in the setting of venous thrombosis
The study hypothesis is that patients with venous thrombosis may have an increased prevalence of CHIP andor an increased NETosis formation which may represent a predisposition for the occurrence of venous thrombosis We also speculate that patients with CHIP may have an increased NETosis due to the presence of activating clonal mutations in neutrophils
Patients included will be younger than 50-years-old with repeated thrombosis or thrombosis of unusual sites cerebral venous thrombosis splanchnic thrombosis with a negative etiological workup and notably the absence of constitutional or acquired venous thrombosis risk factors In this population we will analyze the prevalence of CHIP and the NETosis via the study of 4 different NETosis plasmatic markers
The study hypothesis is that patients with venous thrombosis may have an increased prevalence of CHIP andor an increased NETosis formation which may represent a predisposition for the occurrence of venous thrombosis We also speculate that patients with CHIP may have an increased NETosis due to the presence of activating clonal mutations in neutrophils
Patients included will be younger than 50-years-old with repeated thrombosis or thrombosis of unusual sites cerebral venous thrombosis splanchnic thrombosis with a negative etiological workup and notably the absence of constitutional or acquired venous thrombosis risk factors In this population we will analyze the prevalence of CHIP and the NETosis via the study of 4 different NETosis plasmatic markers
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None