Graduated Compression Stockings (GCS) Pilot Substudy

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)

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.

Study Overview

• Status: Completed
• Conditions: Venous Thromboembolism
• Intervention / Treatment: Device: Anti-Embolism Graduated Pressure Stockings (by BSN-Jobst); Device: No Graduated Compression Stockings

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Phase 3

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Hamilton, Ontario, Canada
      • Henderson Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Randomized to PeriOperative ISchemic Evaluation-2 Trial (POISE-2 Trial)

Exclusion Criteria:

• Unable to wear a graduated compression stockings on a leg that has been operated on (e.g., below knee skin grafting)
• Leg has not been operated on and graduated compression stockings cannot be worn on either leg (e.g. bilateral leg amputations or skin ulceration, allergy to material in the graduated compression stockings)
• Graduated compression stockings cannot be fitted because the patient's legs are too big, or too small (not compatible with manufacturer's recommendations)
• The responsible physician/nurse judges that graduated compression stockings are contraindicated because of: i) decreased circulation in the legs as evidenced by very pale, cyanotic, or gangrenous conditions; or ii) risk of stocking-induced skin necrosis due to an established sensory neuropathy with numbness to touch.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: FACTORIAL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: Anti-Em/GP
OTHER: No Graduated Compression Stockings	Device: No Graduated Compression Stockings; No stockings will be applied.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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
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

Collaborators and Investigators

• Sponsor: Hamilton Health Sciences Corporation
• Collaborators: McMaster University; BSN Medical Inc
• Investigators: Principal Investigator: Clive Kearon, MB, PhD, McMaster University

Study record dates

Study Major Dates

• Study Start: November 1, 2010
• Primary Completion (ACTUAL): December 1, 2011
• Study Completion (ACTUAL): December 1, 2011

Study Registration Dates

• First Submitted: November 2, 2010
• First Submitted That Met QC Criteria: November 3, 2010
• First Posted (ESTIMATE): November 4, 2010

Study Record Updates

• Last Update Posted (ESTIMATE): January 18, 2012
• Last Update Submitted That Met QC Criteria: January 16, 2012
• Last Verified: December 1, 2011

More Information

Terms related to this study

• Keywords: Randomized Controlled Trial; Noncardiac Surgery; Symptomatic Venous Thromboembolism; Graduated Compression Stockings
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Embolism and Thrombosis; Thromboembolism; Venous Thromboembolism
• Other Study ID Numbers: GCS Pilot Substudy