Ignite Creation Date:
2024-05-06 @ 8:27 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06386107
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-26
First Post:
2024-01-22
Brief Title:
Thrombin Generation Parameters and Bleeding in Patients Treated With Anticoagulants for Cancer Associated Thrombosis
Sponsor:
Centre Hospitalier Universitaire de Saint Etienne
Organization:
Centre Hospitalier Universitaire de Saint Etienne
Study Overview
Official Title:
Association Between Thrombin Generation Parameters and the Risk of Bleeding in Patients Treated With Anticoagulants for Cancer Associated Thrombosis CAT a Multicenter Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
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:
CATforCAT
Brief Summary:
Pulmonary embolism the second leading cause of death in cancer patients is effectively treated with anticoagulants In patients with cancer-associated thrombosis CAT the use of anticoagulants is associated with 10 to 15 of bleeding in the first 6 months Most of the guidelines propose to integrate the bleeding risk in the choice of therapies Thrombin generation assay TGA reflects an overall hemostatic response and could be a useful biomarker Proven on the thrombotic side in the CAT population useful in the assessment of the bleeding risk of hemophiliac patients the TGA is emerging as a tool The investigators to measure TGA in cancer patients included prospectively having recently developed a CAT and to evaluate the association between the measurement and the risk of hemorrhagic complication under anticoagulant during the first 6 month of treatment
Detailed Description:
Pulmonary embolism the second leading cause of death in cancer patients is effectively treated with anticoagulants In patients with cancer-associated thrombosis CAT the use of anticoagulants is associated with 10 to 15 of bleeding in the first 6 months Most of the guidelines propose to integrate the bleeding risk in the choice of therapies Existing models for predicting anticoagulant associated bleeding risk applied to the CAT patients are not very predictive AUC060 Thrombin generation assay TGA reflects an overall hemostatic response and could be a useful biomarker Proven on the thrombotic side in the CAT population useful in the assessment of the bleeding risk of hemophiliac patients the TGA is emerging as a tool The investigators wish to measure TGA in cancer patients included prospectively having recently developed a CAT and to evaluate the association between the measurement and the risk of hemorrhagic complication under anticoagulant during the first 6 month of treatment
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2023-A02175-40 | OTHER | ANSM | None |