Graduated Compression Stockings (GCS) Pilot Substudy
|ClinicalTrials.gov Identifier: NCT01234064|
Recruitment Status : Completed
First Posted : November 4, 2010
Last Update Posted : January 18, 2012
|Condition or disease||Intervention/treatment||Phase|
|Venous Thromboembolism||Device: Anti-Embolism Graduated Pressure Stockings (by BSN-Jobst) Device: No Graduated Compression Stockings||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||50 participants|
|Intervention Model:||Factorial Assignment|
|Masking:||None (Open Label)|
|Official Title:||Graduated Compression Stockings (GCS) for Prevention of Venous Thromboembolism in Patients Who Have Major Surgery: Pilot Study Assessing Feasibility of Adding This Evaluation to the PeriOperative ISchemic Evaluation-2 Trial (POISE-2 Trial)|
|Study Start Date :||November 2010|
|Actual Primary Completion Date :||December 2011|
|Actual Study Completion Date :||December 2011|
|Active Comparator: Graduated Compression Stockings||
Device: Anti-Embolism Graduated Pressure Stockings (by BSN-Jobst)
Apply 2 to 4 hours prior to surgery. Patient will continue to wear stockings until post-op Day 10.
Other Name: Anti-Em/GP
|No Graduated Compression Stockings||
Device: No Graduated Compression Stockings
No stockings will be applied.
- Objectively confirmed symptomatic major venous thromboembolism [ Time Frame: 30 days ]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).
- Any symptomatic venous thromboembolism or pulmonary embolism [ Time Frame: 30 days ]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.
- Major venous thromboembolism and death [ Time Frame: 30 Days ]Secondary outcomes to assess efficacy will include patients who, within 30 days, have major venous thromboembolism and death.
- Safety Outcomes [ Time Frame: 30 Days ]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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01234064
|Hamilton, Ontario, Canada|
|Principal Investigator:||Clive Kearon, MB, PhD||McMaster University|