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| Name | Class |
|---|---|
| BSN Medical Inc | INDUSTRY |
| McMaster University | OTHER |
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This is a pilot substudy to the PeriOperative ISchemic Evaluation-2 Trial (POISE-2), to assess the feasibility of adding graduated compression stockings (GCS) to POISE-2 as an intervention.
Objective: To determine if thigh-level graduated compression stockings (below-knee graduated compression stockings may be used if thigh level graduated compression stockings are not feasible, such as after knee surgery), started before surgery and worn until discharge and for a minimum of 10 days (whichever is longer), reduce symptomatic venous thromboembolism (proximal deep vein thrombosis or pulmonary embolism) in the 30 days after surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Graduated Compression Stockings | Active Comparator |
| |
| No Graduated Compression Stockings | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Anti-Embolism Graduated Pressure Stockings (by BSN-Jobst) | Device | Apply 2 to 4 hours prior to surgery. Patient will continue to wear stockings until post-op Day 10. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Objectively confirmed symptomatic major venous thromboembolism | The primary outcome to assess efficacy will be a comparison of the proportion of patients who have objectively confirmed symptomatic major venous thromboembolism (defined as proximal deep vein thrombosis or pulmonary embolism) within 30 days of randomization (includes episodes that are diagnosed in response to symptoms reported at the 30 day assessment). | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Any symptomatic venous thromboembolism or pulmonary embolism | Secondary outcomes to assess efficacy will include patients who, within 30 days, have any symptomatic venous thromboembolism (defined as deep vein thrombosis [including that which is confined to the calf veins] or pulmonary embolism) within 30 days of randomization. | 30 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clive Kearon, MB, PhD | McMaster University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Henderson Hospital | Hamilton | Ontario | Canada |
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| ID | Term |
|---|---|
| D054556 | Venous Thromboembolism |
| ID | Term |
|---|---|
| D013923 | Thromboembolism |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| No Graduated Compression Stockings | Device | No stockings will be applied. |
|
| Major venous thromboembolism and death |
Secondary outcomes to assess efficacy will include patients who, within 30 days, have major venous thromboembolism and death. |
| 30 Days |
| Safety Outcomes | Harm from graduated compression stockings will be assessed as proportion of patients who develop: 1) a new or worsening skin rash that required new, or an increase of, topical or systemic treatment; 2) blistering (defined as at least one blister >1cm in length); 3) pressure sores (minimum of non-blanchable erythema of intact skin); and 4) leg or foot ischaemia (defined as new symptoms (cold, painful, numbness) or new signs (pulseless, cold, absent skin perfusion on release of pressure, absent sensation) that are attributed to ischaemia by a physician. | 30 Days |