Bleeding, Deep Vein Thrombosis of Lower Limb, Pulmonary Embolism (PE)
Conditions
Keywords
SAFE, CECT, SFT, ActiveCare, ActiveCare+SFT, Deep Vein Thrombosis prevention, Total Hip Replacement, Total Hip Arthroplasty, Low Molecular Weight Heparin, MCS
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 \[81 mg\]).
Interventions
DEVICEActiveCare 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.
DRUGEnoxaparin
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.
Sponsors
Medical Compression Systems
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Events of Deep Vein Thrombosis (DVT) | 10-12 days post-op; and from day of surgery and up to 3 months if symptomatic | 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 | Day of surgery and up to 3 months | Clinical PE events PE (Pulmonary Embolism) events were confirmed by spiral CT |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Major Bleeding Complication | Up to 30 days | 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 | 10-12 days post-op | 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 | SAE data were collected Up to 3 months post-op | 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 | Surgery till discharge | 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. |
Countries
United States
Participant flow
Recruitment details
Multi-center study. Recruitment began June 2006 and ended September 2008
Pre-assignment details
Per protocol:. The pre-randomization evaluation (within 3 days of surgery, may be completed on admission) includes the following: * Review of inclusion/exclusion criteria (including evaluation for clinical signs and symptoms of DVT or PE) * Demographic parameters * Medical history
Participants by arm
| Arm | Count |
|---|---|
| ActiveCare+SFT (Experimental) The ActiveCare+SFT device is a mobile compression device used to prevent venous thromboembolic events. It was started immediately after the induction of anesthesia, throughout the surgery and for 10-12 days after surgery (in and out hospital). | 198 |
| LMWH (Enoxaparin) (Active Comparator) Enoxaparin (LMWH) was used, following a protocol that is considered a standard of care for this patient population. 30mg twice a day was given in the hospital and 40mg QD for the remainder of the 10 days (out of hospital). | 194 |
| Total | 392 |
Baseline characteristics
| Characteristic | LMWH (Enoxaparin) (Active Comparator) | Total | ActiveCare+SFT (Experimental) |
|---|---|---|---|
| Age, Continuous | 62 years | 62.5 years | 63 years |
| body-mass index (Kg/m2) | 29 Kg/m^2 | 28.5 Kg/m^2 | 28 Kg/m^2 |
| Diagnosis of osteoarthritis (n) Diagnosis | 184 participants | 370 participants | 186 participants |
| Diagnosis of osteoarthritis (n) No Diagnosis | 10 participants | 22 participants | 12 participants |
| Duration of surgery (minutes) | 96 Minutes | 93.5 Minutes | 91 Minutes |
| length of hospital stay (days) | 3.2 days | 3.2 days | 3.2 days |
| Sex: Female, Male Female | 105 Participants | 214 Participants | 109 Participants |
| Sex: Female, Male Male | 89 Participants | 178 Participants | 89 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 89 / 198 | 102 / 194 |
| serious Total, serious adverse events | 3 / 198 | 10 / 194 |
Outcome results
Primary
Clinical PE (Pulmonary Embolism) Events
Clinical PE events PE (Pulmonary Embolism) events were confirmed by spiral CT
Time frame: Day of surgery and up to 3 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ActiveCare+SFT (Experimental) | Clinical PE (Pulmonary Embolism) Events | 2 Events |
| LMWH (Enoxaparin) (Active Comparator) | Clinical PE (Pulmonary Embolism) Events | 2 Events |
p-value: >0.05Chi-squared
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
Time frame: 10-12 days post-op; and from day of surgery and up to 3 months if symptomatic
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ActiveCare+SFT (Experimental) | Events of Deep Vein Thrombosis (DVT) | Total DVT | 8 Events |
| ActiveCare+SFT (Experimental) | Events of Deep Vein Thrombosis (DVT) | Distal DVT | 5 Events |
| ActiveCare+SFT (Experimental) | Events of Deep Vein Thrombosis (DVT) | Proximal DVT | 3 Events |
| LMWH (Enoxaparin) (Active Comparator) | Events of Deep Vein Thrombosis (DVT) | Total DVT | 8 Events |
| LMWH (Enoxaparin) (Active Comparator) | Events of Deep Vein Thrombosis (DVT) | Distal DVT | 6 Events |
| LMWH (Enoxaparin) (Active Comparator) | Events of Deep Vein Thrombosis (DVT) | Proximal DVT | 2 Events |
p-value: >0.05Chi-squared
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.
Time frame: Surgery till discharge
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ActiveCare+SFT (Experimental) | In-Patients' Compliance | 91 percentage of usage time |
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.
Time frame: Up to 30 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ActiveCare+SFT (Experimental) | Major Bleeding Complication | 0 Events |
| LMWH (Enoxaparin) (Active Comparator) | Major Bleeding Complication | 11 Events |
p-value: 0.0004Chi-squared
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.
Time frame: 10-12 days post-op
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ActiveCare+SFT (Experimental) | OutPatient Patients' Compliance | 83 percentage of usage time |
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
Time frame: SAE data were collected Up to 3 months post-op
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ActiveCare+SFT (Experimental) | Serious Adverse Events | 3 events |
| LMWH (Enoxaparin) (Active Comparator) | Serious Adverse Events | 10 events |
Post Hoc
Allogeneic Blood Transfusion Units
Allogeneic blood transfusion per patient in specific treatment Group
Time frame: Up to 30 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ActiveCare+SFT (Experimental) | Allogeneic Blood Transfusion Units | 0.13 Avg. Unit per patient in arm | Standard Deviation 0.48 |
| LMWH (Enoxaparin) (Active Comparator) | Allogeneic Blood Transfusion Units | 0.32 Avg. Unit per patient in arm | Standard Deviation 0.8 |
p-value: 0.01Chi-squared
Post Hoc
Autologous Blood Transfusion Units
Autologous blood transfusion per patient in specific treatment Group
Time frame: Up to 30 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ActiveCare+SFT (Experimental) | Autologous Blood Transfusion Units | 0.28 Avg. Unit per patient in arm | Standard Deviation 0.53 |
| LMWH (Enoxaparin) (Active Comparator) | Autologous Blood Transfusion Units | 0.3 Avg. Unit per patient in arm | Standard Deviation 0.52 |
p-value: 0.507Chi-squared
Post Hoc
Bleeding Index ≥ 2
Bleeding index was defined as the number of units of whole blood or packed red blood cells transfused plus the difference between the first hemoglobin value after surgery and the value prior to discharge
Time frame: Surgery till discharge
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ActiveCare+SFT (Experimental) | Bleeding Index ≥ 2 | 1.3 units on a scale | Standard Deviation 1.04 |
| LMWH (Enoxaparin) (Active Comparator) | Bleeding Index ≥ 2 | 1.5 units on a scale | Standard Deviation 1.27 |
p-value: 0.052Chi-squared
Post Hoc
Changes in Hemoglobin Levels
Changes in Hemoglobin levels
Time frame: After surgery untill discharge
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ActiveCare+SFT (Experimental) | Changes in Hemoglobin Levels | 8 mean change (g/l) | Standard Deviation 1.26 |
| LMWH (Enoxaparin) (Active Comparator) | Changes in Hemoglobin Levels | 9 mean change (g/l) | Standard Deviation 1.47 |
p-value: 0.798Chi-squared
Post Hoc
Composite Outcome of Major Bleeding + VTE
Major bleeding + DVT events + PE Events
Time frame: Day of surgery and up to 3 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ActiveCare+SFT (Experimental) | Composite Outcome of Major Bleeding + VTE | 10 Events |
| LMWH (Enoxaparin) (Active Comparator) | Composite Outcome of Major Bleeding + VTE | 21 Events |
p-value: 0.036Chi-squared
Post Hoc
Events of Clinical Sign and Symptoms of VTE (DVT and/or PE)
Events of clinical Sign and symptoms of VTE (DVT and/or PE), confirmed by standard objective diagnostic methods
Time frame: Day of surgery and up to 3 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ActiveCare+SFT (Experimental) | Events of Clinical Sign and Symptoms of VTE (DVT and/or PE) | 10 Events |
| LMWH (Enoxaparin) (Active Comparator) | Events of Clinical Sign and Symptoms of VTE (DVT and/or PE) | 10 Events |
p-value: 0.953Chi-squared
Post Hoc
Total Number of Blood Transfusion Units
Number of blood units used (Autologous units and allogeneic units) (blood units during surgery not included)
Time frame: Between the immediate postoperative measurement and discharge
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ActiveCare+SFT (Experimental) | Total Number of Blood Transfusion Units | 82 Units |
| LMWH (Enoxaparin) (Active Comparator) | Total Number of Blood Transfusion Units | 122 Units |
p-value: 0.05Chi-squared