Deep Vein Thrombosis (DVT) Prevention in Total Hip Arthroplasty: Continuous Enhanced Circulation Therapy (CECT) Versus Low Molecular Weight Heparin (LMWH)

Bleeding Clinical Trial

— SAFE  

Official title:

Deep Vein Thrombosis (DVT) Prevention in Total Hip Arthroplasty (THA): Continuous Enhanced Circulation Therapy (CECT) Versus Low Molecular Weight Heparin (LMWH)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00358735
• Other study ID #: MedicalCS06CC001
• Status: Completed
• Phase: N/A
• First received: July 30, 2006
• Last updated: October 21, 2014
• Start date: June 2006
• Est. completion date: December 2008

Study information

• Verified date: October 2014
• Source: Medical Compression Systems
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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]).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 411
• Est. completion date: December 2008
• Est. primary completion date: September 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

Adult patient (Age >18). Patient intended to undergo elective primary unilateral THA surgery. Patient is able and willing to follow instructions of care after surgery. Patient is able and willing to sign the institution human subjects committee approved Informed Consent Form.

Exclusion Criteria:

Patient who has a known coagulation disorder. Patient currently treated with anticoagulant medications. Patient with known thrombophilia Patient with current signs and symptoms of or history of DVT/PE. Patient who is uncooperative or unable to follow instructions. Patient currently suffering from a solid tumor malignancy. Patient with active peptic disease. Patient with known allergy to baby aspirin (81 mg) or enoxaparin. Patient with contraindication to use of the device including patients with leg gangrene, recent skin graft or medical situations where increase venous and lymphatic return is undesirable.Patient has major surgery procedure within 3 months prior to the study surgery, or patients with a major surgery procedure planning during the study period.Pregnant women.Patient who is participating in another clinical drug trial.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Bleeding
• Deep Vein Thrombosis of Lower Limb
• Pulmonary Embolism
• Pulmonary Embolism (PE)
• Thrombosis
• Venous Thrombosis

Intervention

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.

Drug:
• Enoxaparin
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.

Locations

Country	Name	City	State
United States	Center for Joint Preservation and Replacement, Sinai Hospital of Baltimore	Baltimore	Maryland
United States	The Center Orthopedic & Neurosurgical Care &Research	Bend	Oregon
United States	Cleveland Clinic	Cleveland	Ohio
United States	Scripps Clinic	La Jolla	California
United States	Empire Orthopedic Center	Loma Linda	California
United States	Cedars-Sinai Medical Center	Los Angeles	California
United States	The center for hip and knee surgery	Mooresville	Indiana
United States	Hospital for Special Surgery	New York	New York
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Medical Compression Systems

Country where clinical trial is conducted

United States, 

References & Publications (1)

Colwell CW Jr, Froimson MI, Mont MA, Ritter MA, Trousdale RT, Buehler KC, Spitzer A, Donaldson TK, Padgett DE. Thrombosis prevention after total hip arthroplasty: a prospective, randomized trial comparing a mobile compression device with low-molecular-wei — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Events of Deep Vein Thrombosis (DVT)	10-12 days post-op: All of the patients underwent Routine bilateral compression Doppler.; Day of surgery and up to 3 months post-op: Suspected clinical signs and symptoms DVT events were confirmed by standard diagnostic objective methods	10-12 days post-op; and from day of surgery and up to 3 months if symptomatic	No
Primary	Clinical PE (Pulmonary Embolism) Events	Clinical PE events PE (Pulmonary Embolism) events were confirmed by spiral CT	Day of surgery and up to 3 months	No
Secondary	Major Bleeding Complication	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. Data collected included bleeding index, a decrease in hemoglobin greater than/equal to 20 g/L, and number of units of blood transfused.	Up to 30 days	Yes
Secondary	OutPatient Patients' Compliance	Total usage time with the pneumatic device (patient's compliance) was recorded using the ActiveCare+SFT device internal timer.; The compliance was calculate as total actual operation time (for the entire arm/group) divided by the total time passes since the initiation of home treatment (for the entire arm/group).; The compliance is expressed as percentages.	10-12 days post-op	No
Secondary	Serious Adverse Events	Serious Adverse Events (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.; SAE did not include Venous thrombolembolism (VTE) events (DVT and PE) and Major bleeding complications as these are outcome measures	SAE data were collected Up to 3 months post-op	Yes
Secondary	In-Patients' Compliance	Total usage time with the pneumatic device (patient's compliance) was recorded using the ActiveCare+SFT device internal timer.; The compliance was calculate as total actual operation time (for the entire arm/group) divided by the total time passes since the initiation of treatment at hospital (for the entire arm/group).; The compliance is expressed as percentages.	Surgery till discharge	No