Deep Vein Thrombosis (DVT) Prevention in Total Hip Arthroplasty: Continuous Enhanced Circulation Therapy (CECT) Versus Low Molecular Weight Heparin (LMWH) (SAFE)
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.
Deep Vein Thrombosis of Lower Limb
Pulmonary Embolism (PE)
Device: ActiveCare CECT device
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
|Official Title:||Deep Vein Thrombosis (DVT) Prevention in Total Hip Arthroplasty (THA): Continuous Enhanced Circulation Therapy (CECT) Versus Low Molecular Weight Heparin (LMWH)|
- Deep vein thrombosis (DVT) [ Time Frame: 10-12 days post-op; up to 3 months post-op ] [ Designated as safety issue: No ]Patients will be examined for clinical signs and symptoms of Deep Vein thrombosis (DVT). Suspected clinical DVT events during the followup period will be confirmed by standard diagnostic objective methods.
- Pulmonary Embolism (PE) [ Time Frame: up to 3 months post-op ] [ Designated as safety issue: No ]Suspected clinical PE events during this followup period will be confirmed by standard objective diagnostic methods.
- Bleeding [ Time Frame: Up to 3 months post-op ] [ Designated as safety issue: Yes ]Major bleeding is defined as bleeding that requires rehospitalization or prolonged hospitalization, requires any intervention such as surgery or hematoma aspiration to prevent permanent impairment or damage, endangered critical organs, is life threatening or causes death. Minor bleeding is any bleeding not considered major bleeding (e.g., increased wound drainage or drop in hemoglobin not requiring transfusion or prolonged hospitalization). Data collected will include bleeding index, a decrease in hemoglobin greater than/equal to 20 g/L, and number of units of blood transfused.
- Adverse events [ Time Frame: At discharge; Up to 3 months post-op ] [ Designated as safety issue: Yes ]An adverse event is any undesirable experience (sign, symptom, illness, abnormal laboratory value, or other medical event) occurring to a patient that appears or worsens during a clinical study. A serious adverse event (SAE) is any event that prolongs hospitalization or requires re-hospitalization, that requires intervention to prevent permanent impairment or damage, that causes permanent disability, or that is life threatening.
- Patient's compliance (CECT group). [ Time Frame: 10-12 days post-op ] [ Designated as safety issue: No ]Total pneumatic usage time and patient's compliance will be recorded using the device internal timer.
|Study Start Date:||June 2006|
|Study Completion Date:||December 2008|
|Primary Completion Date:||September 2008 (Final data collection date for primary outcome measure)|
Experimental: ActiveCare CECT
The ActiveCare CECT device is a mobile compression device used to prevent venous thromboembolic events, used after the induction of anesthesia, throughout the surgery and for 10-12 days after surgery.
Device: ActiveCare CECT device
Patients will be treated with the ActiveCare+ CECT device starting after the induction of anesthesia, throughout the surgery and for 10-12 days after surgery. Baby aspirin (81 mg) QD can be added (depending on surgeon preference) 12-24 hours after surgery. Post discharge prophylaxis is the same for the remainder of the 10-12 days. Patients will wear the device to the duplex ultrasound when it will be discontinued by nurse.
Active Comparator: LMWH (Enoxaparin)
Enoxaparin (LMWH) will be used, following a protocol that is considered a standard of care for this patient population. 40mg QD for the remainder of the 10 days.
Patients will be treated with Enoxaparin (Lovenox) for a total of 10 days beginning with 30mg BID starting 12-24 hours after surgery and continued until hospital discharge. Post discharge prophylaxis will be Enoxaparin 40mg QD for the remainder of the 10 days.
Other Name: Lovenox
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]).
Please refer to this study by its ClinicalTrials.gov identifier: NCT00358735
|United States, California|
|La Jolla, California, United States, 92037|
|Empire Orthopedic Center|
|Loma Linda, California, United States, 92324|
|Cedars-Sinai Medical Center|
|Los Angeles, California, United States, 90048|
|United States, Indiana|
|The center for hip and knee surgery|
|Mooresville, Indiana, United States, 46158|
|United States, Maryland|
|Center for Joint Preservation and Replacement, Sinai Hospital of Baltimore|
|Baltimore, Maryland, United States, 21215|
|United States, Minnesota|
|Rochester, Minnesota, United States, 55902|
|United States, New York|
|Hospital for Special Surgery|
|New York, New York, United States, 10021|
|United States, Ohio|
|Cleveland, Ohio, United States, 44195|
|United States, Oregon|
|The Center Orthopedic & Neurosurgical Care &Research|
|Bend, Oregon, United States, 97701|
|Principal Investigator:||Clifford W Colwell, M.D||Scripps Clinic|