Ignite Creation Date:
2024-05-06 @ 4:53 PM
Last Modification Date:
2024-10-26 @ 2:18 PM
Study NCT ID:
NCT05128214
Status:
UNKNOWN
Last Update Posted:
2021-11-30
First Post:
2021-10-14
Brief Title:
Aspirin Thromboprophylaxis After First-line Total Hip and Knee Replacement
Sponsor:
University Hospital Strasbourg France
Organization:
University Hospital Strasbourg France
Study Overview
Official Title:
Aspirin Thromboprophylaxis After First-line Total Hip and Knee Replacement Comparison With Baseline Low Molecular Weight Heparin Prophylaxis
Status:
UNKNOWN
Status Verified Date:
2021-10
Last Known Status:
RECRUITING
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:
TBP-ASPIR
Brief Summary:
Annually more than 100000 total hip prostheses THA and more than 100000 total knee prostheses TKA are implanted for osteoarthritis in France and these figures are set to increase significantly in the future as in all industrialized countries Venous thrombosis is a potentially serious complication after PTH and PTG justifying various prophylactic measures In France aggressive prophylaxis with low molecular weight heparin LMWH or direct oral anticoagulants DOA was until recently recommended because this drug is considered to be the most effective at the cost of a bleeding risk implicitly assumed but often poorly evaluated A recent publication suggests that the risk of bleeding is currently greater than the risk of a thromboembolic event
More recently foreign or international recommendations have broadened the range of these recommendations notably by introducing aspirin as a possible prophylactic agent While this molecule is potentially less effective than LMWHs or ADOs it could decrease the risk of iatrogenic hemorrhage The introduction of enhanced recovery procedures after surgery RAAC could decrease the risk of thrombosis without modifying the risk of bleeding and thereby improve the cost-benefit ratio of aspirin justifying its recent inclusion in the current French recommendations when The operated follows such a protocol
More recently foreign or international recommendations have broadened the range of these recommendations notably by introducing aspirin as a possible prophylactic agent While this molecule is potentially less effective than LMWHs or ADOs it could decrease the risk of iatrogenic hemorrhage The introduction of enhanced recovery procedures after surgery RAAC could decrease the risk of thrombosis without modifying the risk of bleeding and thereby improve the cost-benefit ratio of aspirin justifying its recent inclusion in the current French recommendations when The operated follows such a protocol
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