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Graduated Compression Stockings (GCS) Pilot Substudy

Primary Purpose

Venous Thromboembolism

Status
Completed
Phase
Phase 3
Locations
Canada
Study Type
Interventional
Intervention
Anti-Embolism Graduated Pressure Stockings (by BSN-Jobst)
No Graduated Compression Stockings
Sponsored by
Hamilton Health Sciences Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Venous Thromboembolism focused on measuring Symptomatic Venous Thromboembolism, Graduated Compression Stockings, Randomized Controlled Trial, Noncardiac Surgery

Eligibility Criteria

45 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Henderson Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Other

Arm Label

Graduated Compression Stockings

No Graduated Compression Stockings

Arm Description

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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.
Major venous thromboembolism and death
Secondary outcomes to assess efficacy will include patients who, within 30 days, have major venous thromboembolism and death.
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.

Full Information

First Posted
November 2, 2010
Last Updated
January 16, 2012
Sponsor
Hamilton Health Sciences Corporation
Collaborators
BSN Medical Inc, McMaster University
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1. Study Identification

Unique Protocol Identification Number
NCT01234064
Brief Title
Graduated Compression Stockings (GCS) Pilot Substudy
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 Type
Interventional

2. Study Status

Record Verification Date
December 2011
Overall Recruitment Status
Completed
Study Start Date
November 2010 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
December 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hamilton Health Sciences Corporation
Collaborators
BSN Medical Inc, McMaster University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Venous Thromboembolism
Keywords
Symptomatic Venous Thromboembolism, Graduated Compression Stockings, Randomized Controlled Trial, Noncardiac Surgery

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Graduated Compression Stockings
Arm Type
Active Comparator
Arm Title
No Graduated Compression Stockings
Arm Type
Other
Intervention Type
Device
Intervention Name(s)
Anti-Embolism Graduated Pressure Stockings (by BSN-Jobst)
Other Intervention Name(s)
Anti-Em/GP
Intervention Description
Apply 2 to 4 hours prior to surgery. Patient will continue to wear stockings until post-op Day 10.
Intervention Type
Device
Intervention Name(s)
No Graduated Compression Stockings
Intervention Description
No stockings will be applied.
Primary Outcome Measure Information:
Title
Objectively confirmed symptomatic major venous thromboembolism
Description
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).
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Any symptomatic venous thromboembolism or pulmonary embolism
Description
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.
Time Frame
30 days
Title
Major venous thromboembolism and death
Description
Secondary outcomes to assess efficacy will include patients who, within 30 days, have major venous thromboembolism and death.
Time Frame
30 Days
Title
Safety Outcomes
Description
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.
Time Frame
30 Days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clive Kearon, MB, PhD
Organizational Affiliation
McMaster University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Henderson Hospital
City
Hamilton
State/Province
Ontario
Country
Canada

12. IPD Sharing Statement

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Graduated Compression Stockings (GCS) Pilot Substudy

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