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

Primary Purpose

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

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
ActiveCare CECT device
Enoxaparin
Sponsored by
Medical Compression Systems
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Deep Vein Thrombosis of Lower Limb focused on measuring SAFE, CECT, SFT, ActiveCare, ActiveCare+SFT, Deep Vein Thrombosis prevention, Total Hip Replacement, Total Hip Arthroplasty, Low Molecular Weight Heparin, MCS

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Scripps Clinic
  • Empire Orthopedic Center
  • Cedars-Sinai Medical Center
  • The center for hip and knee surgery
  • Center for Joint Preservation and Replacement, Sinai Hospital of Baltimore
  • Mayo Clinic
  • Hospital for Special Surgery
  • Cleveland Clinic
  • The Center Orthopedic & Neurosurgical Care &Research

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

ActiveCare CECT

LMWH (Enoxaparin)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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
Clinical PE (Pulmonary Embolism) Events
Clinical PE events PE (Pulmonary Embolism) events were confirmed by spiral CT

Secondary Outcome Measures

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.
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.
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
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.

Full Information

First Posted
July 30, 2006
Last Updated
October 21, 2014
Sponsor
Medical Compression Systems
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1. Study Identification

Unique Protocol Identification Number
NCT00358735
Brief Title
Deep Vein Thrombosis (DVT) Prevention in Total Hip Arthroplasty: Continuous Enhanced Circulation Therapy (CECT) Versus Low Molecular Weight Heparin (LMWH)
Acronym
SAFE
Official Title
Deep Vein Thrombosis (DVT) Prevention in Total Hip Arthroplasty (THA): Continuous Enhanced Circulation Therapy (CECT) Versus Low Molecular Weight Heparin (LMWH)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2014
Overall Recruitment Status
Completed
Study Start Date
June 2006 (undefined)
Primary Completion Date
September 2008 (Actual)
Study Completion Date
December 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medical Compression Systems

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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]).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Deep Vein Thrombosis of Lower Limb, Pulmonary Embolism (PE), Bleeding
Keywords
SAFE, CECT, SFT, ActiveCare, ActiveCare+SFT, Deep Vein Thrombosis prevention, Total Hip Replacement, Total Hip Arthroplasty, Low Molecular Weight Heparin, MCS

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
411 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ActiveCare CECT
Arm Type
Experimental
Arm Description
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.
Arm Title
LMWH (Enoxaparin)
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
ActiveCare CECT device
Other Intervention Name(s)
ActiveCare+, ActiveCare DVT, ActiveCare+SFT
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Enoxaparin
Other Intervention Name(s)
Lovenox
Intervention Description
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.
Primary Outcome Measure Information:
Title
Events of Deep Vein Thrombosis (DVT)
Description
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
Time Frame
10-12 days post-op; and from day of surgery and up to 3 months if symptomatic
Title
Clinical PE (Pulmonary Embolism) Events
Description
Clinical PE events PE (Pulmonary Embolism) events were confirmed by spiral CT
Time Frame
Day of surgery and up to 3 months
Secondary Outcome Measure Information:
Title
Major Bleeding Complication
Description
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.
Time Frame
Up to 30 days
Title
OutPatient Patients' Compliance
Description
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.
Time Frame
10-12 days post-op
Title
Serious Adverse Events
Description
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
Time Frame
SAE data were collected Up to 3 months post-op
Title
In-Patients' Compliance
Description
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.
Time Frame
Surgery till discharge

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clifford W Colwell, M.D
Organizational Affiliation
Scripps Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Scripps Clinic
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
Empire Orthopedic Center
City
Loma Linda
State/Province
California
ZIP/Postal Code
92324
Country
United States
Facility Name
Cedars-Sinai Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
The center for hip and knee surgery
City
Mooresville
State/Province
Indiana
ZIP/Postal Code
46158
Country
United States
Facility Name
Center for Joint Preservation and Replacement, Sinai Hospital of Baltimore
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21215
Country
United States
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55902
Country
United States
Facility Name
Hospital for Special Surgery
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
The Center Orthopedic & Neurosurgical Care &Research
City
Bend
State/Province
Oregon
ZIP/Postal Code
97701
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
20194309
Citation
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.
Results Reference
result
Links:
URL
http://www.mcsmed.com/uploadimages/SAFE.pdf
Description
Summary and brochure of the S.A.F.E study

Learn more about this trial

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

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