Trial Outcomes & Findings for Deep Vein Thrombosis (DVT) Prevention in Total Hip Arthroplasty: Continuous Enhanced Circulation Therapy (CECT) Versus Low Molecular Weight Heparin (LMWH) (NCT NCT00358735)

NCT ID: NCT00358735

Last Updated: 2014-10-30

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 411 participants
• Primary outcome timeframe: 10-12 days post-op; and from day of surgery and up to 3 months if symptomatic
• Results posted on: 2014-10-30

Participant Flow

Multi-center study. Recruitment began June 2006 and ended September 2008

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

Participant milestones

Measure	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).	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).
Overall Study STARTED	204	207
Overall Study Completed Safety	198	194
Overall Study Not Completed Safety	6	13
Overall Study COMPLETED	196	190
Overall Study NOT COMPLETED	8	17

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	ActiveCare+SFT (Experimental) n=198 Participants 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).	LMWH (Enoxaparin) (Active Comparator) n=194 Participants 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).	Total n=392 Participants Total of all reporting groups
Age, Continuous	63 years n=5 Participants	62 years n=7 Participants	62.5 years n=5 Participants
Sex: Female, Male Female	109 Participants n=5 Participants	105 Participants n=7 Participants	214 Participants n=5 Participants
Sex: Female, Male Male	89 Participants n=5 Participants	89 Participants n=7 Participants	178 Participants n=5 Participants
body-mass index (Kg/m2)	28 Kg/m^2 n=5 Participants	29 Kg/m^2 n=7 Participants	28.5 Kg/m^2 n=5 Participants
Diagnosis of osteoarthritis (n) Diagnosis	186 participants n=5 Participants	184 participants n=7 Participants	370 participants n=5 Participants
Diagnosis of osteoarthritis (n) No Diagnosis	12 participants n=5 Participants	10 participants n=7 Participants	22 participants n=5 Participants
Duration of surgery (minutes)	91 Minutes n=5 Participants	96 Minutes n=7 Participants	93.5 Minutes n=5 Participants
length of hospital stay (days)	3.2 days n=5 Participants	3.2 days n=7 Participants	3.2 days n=5 Participants

PRIMARY outcome

Timeframe: 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

Outcome measures

Measure	ActiveCare+SFT (Experimental) n=197 Number of Hips Analyzed 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).	LMWH (Enoxaparin) (Active Comparator) n=192 Number of Hips Analyzed 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).
Events of Deep Vein Thrombosis (DVT) Total DVT	8 Events	8 Events
Events of Deep Vein Thrombosis (DVT) Distal DVT	5 Events	6 Events
Events of Deep Vein Thrombosis (DVT) Proximal DVT	3 Events	2 Events

PRIMARY outcome

Timeframe: Day of surgery and up to 3 months

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

Outcome measures

Measure	ActiveCare+SFT (Experimental) n=197 Number of Hips Analyzed 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).	LMWH (Enoxaparin) (Active Comparator) n=192 Number of Hips Analyzed 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).
Clinical PE (Pulmonary Embolism) Events	2 Events	2 Events

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	ActiveCare+SFT (Experimental) n=199 Number of Hips Analyzed 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).	LMWH (Enoxaparin) (Active Comparator) n=196 Number of Hips Analyzed 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).
Major Bleeding Complication	0 Events	11 Events

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	ActiveCare+SFT (Experimental) n=180 Participants 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).	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).
OutPatient Patients' Compliance	83 percentage of usage time	—

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure	ActiveCare+SFT (Experimental) n=198 Participants 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).	LMWH (Enoxaparin) (Active Comparator) n=194 Participants 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).
Serious Adverse Events	3 events	10 events

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	ActiveCare+SFT (Experimental) n=180 Participants 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).	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).
In-Patients' Compliance	91 percentage of usage time	—

POST_HOC outcome

Timeframe: Day of surgery and up to 3 months

Events of clinical Sign and symptoms of VTE (DVT and/or PE), confirmed by standard objective diagnostic methods

Outcome measures

Measure	ActiveCare+SFT (Experimental) n=197 Number of Hips Analyzed 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).	LMWH (Enoxaparin) (Active Comparator) n=192 Number of Hips Analyzed 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).
Events of Clinical Sign and Symptoms of VTE (DVT and/or PE)	10 Events	10 Events

POST_HOC outcome

Timeframe: Between the immediate postoperative measurement and discharge

Number of blood units used (Autologous units and allogeneic units) (blood units during surgery not included)

Outcome measures

Measure	ActiveCare+SFT (Experimental) n=199 Number of Hips Analyzed 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).	LMWH (Enoxaparin) (Active Comparator) n=196 Number of Hips Analyzed 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).
Total Number of Blood Transfusion Units	82 Units	122 Units

POST_HOC outcome

Timeframe: Up to 30 days

Allogeneic blood transfusion per patient in specific treatment Group

Outcome measures

Measure	ActiveCare+SFT (Experimental) n=198 Participants 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).	LMWH (Enoxaparin) (Active Comparator) n=194 Participants 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).
Allogeneic Blood Transfusion Units	0.13 Avg. Unit per patient in arm Standard Deviation 0.48	0.32 Avg. Unit per patient in arm Standard Deviation 0.8

POST_HOC outcome

Timeframe: Up to 30 days

Autologous blood transfusion per patient in specific treatment Group

Outcome measures

Measure	ActiveCare+SFT (Experimental) n=198 Participants 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).	LMWH (Enoxaparin) (Active Comparator) n=194 Participants 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).
Autologous Blood Transfusion Units	0.28 Avg. Unit per patient in arm Standard Deviation 0.53	0.3 Avg. Unit per patient in arm Standard Deviation 0.52

POST_HOC outcome

Timeframe: Surgery till discharge

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

Outcome measures

Measure	ActiveCare+SFT (Experimental) n=198 Participants 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).	LMWH (Enoxaparin) (Active Comparator) n=194 Participants 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).
Bleeding Index ≥ 2	1.3 units on a scale Standard Deviation 1.04	1.5 units on a scale Standard Deviation 1.27

POST_HOC outcome

Timeframe: After surgery untill discharge

Changes in Hemoglobin levels

Outcome measures

Measure	ActiveCare+SFT (Experimental) n=198 Participants 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).	LMWH (Enoxaparin) (Active Comparator) n=194 Participants 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).
Changes in Hemoglobin Levels	8 mean change (g/l) Standard Deviation 1.26	9 mean change (g/l) Standard Deviation 1.47

POST_HOC outcome

Timeframe: Day of surgery and up to 3 months

Major bleeding + DVT events + PE Events

Outcome measures

Measure	ActiveCare+SFT (Experimental) n=196 Participants 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).	LMWH (Enoxaparin) (Active Comparator) n=190 Participants 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).
Composite Outcome of Major Bleeding + VTE	10 Events	21 Events

Adverse Events

ActiveCare+SFT (Experimental)

Serious events: 3 serious events

Other events: 89 other events

Deaths: 0 deaths

LMWH (Enoxaparin) (Active Comparator)

Serious events: 10 serious events

Other events: 102 other events

Deaths: 0 deaths

Serious adverse events

Measure	ActiveCare+SFT (Experimental) n=198 participants at risk 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).	LMWH (Enoxaparin) (Active Comparator) n=194 participants at risk 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).
Cardiac disorders Cardiac Disorders	0.00% 0/198 • SAE data were collected Up to 3 months post-op SAE did not include VTE events(DVT and PE) and Major bleeding complications as these are outcome measures	0.52% 1/194 • SAE data were collected Up to 3 months post-op SAE did not include VTE events(DVT and PE) and Major bleeding complications as these are outcome measures
Musculoskeletal and connective tissue disorders Dislocation	0.00% 0/198 • SAE data were collected Up to 3 months post-op SAE did not include VTE events(DVT and PE) and Major bleeding complications as these are outcome measures	2.6% 5/194 • SAE data were collected Up to 3 months post-op SAE did not include VTE events(DVT and PE) and Major bleeding complications as these are outcome measures
Infections and infestations Fever due to aspiration	0.51% 1/198 • SAE data were collected Up to 3 months post-op SAE did not include VTE events(DVT and PE) and Major bleeding complications as these are outcome measures	0.00% 0/194 • SAE data were collected Up to 3 months post-op SAE did not include VTE events(DVT and PE) and Major bleeding complications as these are outcome measures
Nervous system disorders Parkinson (new event)	0.51% 1/198 • SAE data were collected Up to 3 months post-op SAE did not include VTE events(DVT and PE) and Major bleeding complications as these are outcome measures	0.00% 0/194 • SAE data were collected Up to 3 months post-op SAE did not include VTE events(DVT and PE) and Major bleeding complications as these are outcome measures
Musculoskeletal and connective tissue disorders Stress fracture	0.00% 0/198 • SAE data were collected Up to 3 months post-op SAE did not include VTE events(DVT and PE) and Major bleeding complications as these are outcome measures	0.52% 1/194 • SAE data were collected Up to 3 months post-op SAE did not include VTE events(DVT and PE) and Major bleeding complications as these are outcome measures
Cardiac disorders supraventricular cardiac arrhythmia	0.51% 1/198 • SAE data were collected Up to 3 months post-op SAE did not include VTE events(DVT and PE) and Major bleeding complications as these are outcome measures	1.0% 2/194 • SAE data were collected Up to 3 months post-op SAE did not include VTE events(DVT and PE) and Major bleeding complications as these are outcome measures
Blood and lymphatic system disorders Thrombocytopenia (HIT?)	0.00% 0/198 • SAE data were collected Up to 3 months post-op SAE did not include VTE events(DVT and PE) and Major bleeding complications as these are outcome measures	0.52% 1/194 • SAE data were collected Up to 3 months post-op SAE did not include VTE events(DVT and PE) and Major bleeding complications as these are outcome measures

Other adverse events

Measure	ActiveCare+SFT (Experimental) n=198 participants at risk 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).	LMWH (Enoxaparin) (Active Comparator) n=194 participants at risk 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).
Blood and lymphatic system disorders Minor Bleeding	37.4% 74/198 • Number of events 74 • SAE data were collected Up to 3 months post-op SAE did not include VTE events(DVT and PE) and Major bleeding complications as these are outcome measures	40.2% 78/194 • Number of events 78 • SAE data were collected Up to 3 months post-op SAE did not include VTE events(DVT and PE) and Major bleeding complications as these are outcome measures
Blood and lymphatic system disorders Edema	3.5% 7/198 • Number of events 7 • SAE data were collected Up to 3 months post-op SAE did not include VTE events(DVT and PE) and Major bleeding complications as these are outcome measures	11.3% 22/194 • Number of events 22 • SAE data were collected Up to 3 months post-op SAE did not include VTE events(DVT and PE) and Major bleeding complications as these are outcome measures
Skin and subcutaneous tissue disorders Skin irritation	4.0% 8/198 • Number of events 8 • SAE data were collected Up to 3 months post-op SAE did not include VTE events(DVT and PE) and Major bleeding complications as these are outcome measures	1.0% 2/194 • Number of events 2 • SAE data were collected Up to 3 months post-op SAE did not include VTE events(DVT and PE) and Major bleeding complications as these are outcome measures

Additional Information

Clifford W Colwell, M.D Scripps Clinic

Medical Compression Systems

Phone: 972-4-6266630

Email: Jbarak@mcsmed.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place