| 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 | | Posted | | Number | | Events | | 10-12 days post-op; and from day of surgery and up to 3 months if symptomatic | Number of Hips Analyzed | Participants | | ID | Title | Description |
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| OG000 | 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). | | OG001 | 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). |
| | Units | Counts |
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| Participants | | | Number of Hips Analyzed | |
| | Title | Denominators | Categories |
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| Total DVT | | | | Distal DVT | | |
| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
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| | Chi-squared | | >0.05 | | | | | | | | | | | | | No | Superiority or Other | | |
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| Primary | Clinical PE (Pulmonary Embolism) Events | Clinical PE events PE (Pulmonary Embolism) events were confirmed by spiral CT | | Posted | | Number | | Events | | Day of surgery and up to 3 months | Number of Hips Analyzed | Participants | | ID | Title | Description |
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| OG000 | 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). | | OG001 | 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). |
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| 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. | | Posted | | Number | | Events | | Up to 30 days | Number of Hips Analyzed | Participants | | ID | Title | Description |
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| OG000 | 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). | | OG001 | 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). |
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| 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. | | Posted | | Number | | percentage of usage time | | 10-12 days post-op | | | | ID | Title | Description |
|---|
| OG000 | 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). |
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| 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 | | Posted | | Number | | Events | | Day of surgery and up to 3 months | Number of Hips Analyzed | Participants | | ID | Title | Description |
|---|
| OG000 | 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). | | OG001 | 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). |
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| Post-Hoc | Total Number of Blood Transfusion Units | Number of blood units used (Autologous units and allogeneic units) (blood units during surgery not included) | | Posted | | Number | | Units | | Between the immediate postoperative measurement and discharge | Number of Hips Analyzed | Participants | | ID | Title | Description |
|---|
| OG000 | 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). | | OG001 | 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). |
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| Post-Hoc | Allogeneic Blood Transfusion Units | Allogeneic blood transfusion per patient in specific treatment Group | | Posted | | Mean | Standard Deviation | Avg. Unit per patient in arm | | Up to 30 days | | | | ID | Title | Description |
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| OG000 | 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). | | OG001 | 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). |
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| Post-Hoc | Autologous Blood Transfusion Units | Autologous blood transfusion per patient in specific treatment Group | | Posted | | Mean | Standard Deviation | Avg. Unit per patient in arm | | Up to 30 days | | | | ID | Title | Description |
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| OG000 | 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). | | OG001 | 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). |
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| 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 | | Posted | | Mean | Standard Deviation | units on a scale | | Surgery till discharge | | | | ID | Title | Description |
|---|
| OG000 | 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). | | OG001 | 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). |
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| Post-Hoc | Changes in Hemoglobin Levels | Changes in Hemoglobin levels | | Posted | | Mean | Standard Deviation | mean change (g/l) | | After surgery untill discharge | | | | ID | Title | Description |
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| OG000 | 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). | | OG001 | 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). |
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| Post-Hoc | Composite Outcome of Major Bleeding + VTE | Major bleeding + DVT events + PE Events | | Posted | | Number | | Events | | Day of surgery and up to 3 months | | | | ID | Title | Description |
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| OG000 | 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). | | OG001 | 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). |
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| 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 | | Posted | | Number | | events | | SAE data were collected Up to 3 months post-op | | | | ID | Title | Description |
|---|
| OG000 | 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). | | OG001 | 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). |
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| 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. | | Posted | | Number | | percentage of usage time | | Surgery till discharge | | | | ID | Title | Description |
|---|
| OG000 | 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). |
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