Ignite Creation Date:
2024-05-05 @ 4:56 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00358735
Status:
COMPLETED
Last Update Posted:
2014-10-30
First Post:
2006-07-30
Brief Title:
Deep Vein Thrombosis DVT Prevention in Total Hip Arthroplasty Continuous Enhanced Circulation Therapy CECT Versus Low Molecular Weight Heparin LMWH
Sponsor:
Medical Compression Systems
Organization:
Medical Compression Systems
Study Overview
Official Title:
Deep Vein Thrombosis DVT Prevention in Total Hip Arthroplasty THA Continuous Enhanced Circulation Therapy CECT Versus Low Molecular Weight Heparin LMWH
Status:
COMPLETED
Status Verified Date:
2014-10
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:
SAFE
Brief Summary:
Evaluation of the safety and effectiveness of ActiveCare CECT device - baby dose aspirin 81 mg QD for lowering the potential risk for bleeding and of DVT during and after THA surgery in comparison with LMWH
Detailed Description:
Patients undergoing total hip arthroplasty surgery are at particular risk for Thromboembolic disease To date two prophylactic modalities are being used mechanical intermittent pneumatic compression IPC and pharmacological anticoagulant Both are effective however each carries its own advantages and disadvantages
The purpose of this study is to compare in total hip arthroplasty THA patients the safety and effectiveness of the mobile ActiveCare CECT based prophylaxis protocol and compare it with LMWH standard of care protocol for this patient population
The protocol is based upon the CECT system as the primary DVT prophylaxis method with or without the addition of low dose baby aspirin 81 mg
The purpose of this study is to compare in total hip arthroplasty THA patients the safety and effectiveness of the mobile ActiveCare CECT based prophylaxis protocol and compare it with LMWH standard of care protocol for this patient population
The protocol is based upon the CECT system as the primary DVT prophylaxis method with or without the addition of low dose baby aspirin 81 mg
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None