Deep Vein Thrombosis (DVT) Prevention in Total Hip Arthroplasty: Continuous Enhanced Circulation Therapy (CECT) Versus Low Molecular Weight Heparin (LMWH)
SAFE
1 other identifier
interventional
411
1 country
9
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2006
Typical duration for not_applicable
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2006
CompletedFirst Submitted
Initial submission to the registry
July 30, 2006
CompletedFirst Posted
Study publicly available on registry
August 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2008
CompletedResults Posted
Study results publicly available
October 21, 2014
CompletedOctober 30, 2014
October 1, 2014
2.3 years
July 30, 2006
September 14, 2014
October 21, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
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
Secondary Outcomes (4)
Major Bleeding Complication
Up to 30 days
OutPatient Patients' Compliance
10-12 days post-op
Serious Adverse Events
SAE data were collected Up to 3 months post-op
In-Patients' Compliance
Surgery till discharge
Study Arms (2)
ActiveCare CECT
EXPERIMENTALThe 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.
LMWH (Enoxaparin)
ACTIVE COMPARATOREnoxaparin (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.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (9)
Scripps Clinic
La Jolla, California, 92037, United States
Empire Orthopedic Center
Loma Linda, California, 92324, United States
Cedars-Sinai Medical Center
Los Angeles, California, 90048, United States
The center for hip and knee surgery
Mooresville, Indiana, 46158, United States
Center for Joint Preservation and Replacement, Sinai Hospital of Baltimore
Baltimore, Maryland, 21215, United States
Mayo Clinic
Rochester, Minnesota, 55902, United States
Hospital for Special Surgery
New York, New York, 10021, United States
Cleveland Clinic
Cleveland, Ohio, 44195, United States
The Center Orthopedic & Neurosurgical Care &Research
Bend, Oregon, 97701, United States
Related 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-weight heparin. J Bone Joint Surg Am. 2010 Mar;92(3):527-35. doi: 10.2106/JBJS.I.00047.
PMID: 20194309RESULT
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Clifford W Colwell, M.D Scripps Clinic
- Organization
- Medical Compression Systems
Study Officials
- PRINCIPAL INVESTIGATOR
Clifford W Colwell, M.D
Scripps Clinic
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 30, 2006
First Posted
August 1, 2006
Study Start
June 1, 2006
Primary Completion
September 1, 2008
Study Completion
December 1, 2008
Last Updated
October 30, 2014
Results First Posted
October 21, 2014
Record last verified: 2014-10