Ignite Creation Date:
2024-05-06 @ 8:26 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06382584
Status:
COMPLETED
Last Update Posted:
2024-04-24
First Post:
2023-12-06
Brief Title:
Impact of Treatment With Oral Anticoagulants of Patients With Fractures of the Upper End of the Femur
Sponsor:
Centre Hospitalier Universitaire de Nīmes
Organization:
Centre Hospitalier Universitaire de Nīmes
Study Overview
Official Title:
Impact of Treatment With Direct Oral Anticoagulants Anti Xa on the Management and Outcome of Patients With Fractures of the Upper End of the Femur Retrospective Analysis of Nimes University Hospital Database
Status:
COMPLETED
Status Verified Date:
2023-12
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:
ANTI_XA
Brief Summary:
In 2023 oral anticoagulant treatments anti Xa apixaban rivaroxaban etc are tending to replace anti vitamin K treatments in many medical indications Their prescription is increasing rapidly in the elderly
In this context the Nimes University Hospital receives a large number of elderly patients who have suffered a fracture of the end of the femur requiring surgery and who are taking anti Xa drugsTo avoid massive intra- and post-operative haemorrhage surgical management is postponed because of the need to suspend the treatment allowing a return to near-normal biological haemostasis within a few days No consensus has been reached on the withdrawal period required to authorise surgery as the elimination kinetics of the drug are altered in this context elderly patients dehydration hypovolaemia impaired renal function A plasma assay threshold of 30 to 60 ngmL has been proposed without any real justification This waiting period exposes the elderly to excess mortality Reversing these treatments by adding coagulation factors would be an attractive alternative as it would allow surgery to be performed earlier but this would expose patients to an increased thrombotic risk
Before considering a prospective randomised study early vs delayed surgery on AOD we wish to retrospectively analyse data on patients admitted to the Nimes University Hospital on anti Xa and operated on for fracture of the upper end of the femur between 1 January 2022 and 1 June 2023
In this context the Nimes University Hospital receives a large number of elderly patients who have suffered a fracture of the end of the femur requiring surgery and who are taking anti Xa drugsTo avoid massive intra- and post-operative haemorrhage surgical management is postponed because of the need to suspend the treatment allowing a return to near-normal biological haemostasis within a few days No consensus has been reached on the withdrawal period required to authorise surgery as the elimination kinetics of the drug are altered in this context elderly patients dehydration hypovolaemia impaired renal function A plasma assay threshold of 30 to 60 ngmL has been proposed without any real justification This waiting period exposes the elderly to excess mortality Reversing these treatments by adding coagulation factors would be an attractive alternative as it would allow surgery to be performed earlier but this would expose patients to an increased thrombotic risk
Before considering a prospective randomised study early vs delayed surgery on AOD we wish to retrospectively analyse data on patients admitted to the Nimes University Hospital on anti Xa and operated on for fracture of the upper end of the femur between 1 January 2022 and 1 June 2023
Detailed Description:
None
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