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Graduated Compression Stockings (GCS) Pilot Substudy

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01234064
First Posted: November 4, 2010
Last Update Posted: January 18, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
BSN Medical Inc
McMaster University
Information provided by (Responsible Party):
McMaster University ( Hamilton Health Sciences Corporation )
  Purpose
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.

Condition Intervention Phase
Venous Thromboembolism Device: Anti-Embolism Graduated Pressure Stockings (by BSN-Jobst) Device: No Graduated Compression Stockings Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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)

Further study details as provided by McMaster University ( Hamilton Health Sciences Corporation ):

Primary Outcome Measures:
  • 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).


Secondary Outcome Measures:
  • 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.


Enrollment: 50
Study Start Date: November 2010
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01234064


Locations
Canada, Ontario
Henderson Hospital
Hamilton, Ontario, Canada
Sponsors and Collaborators
Hamilton Health Sciences Corporation
BSN Medical Inc
McMaster University
Investigators
Principal Investigator: Clive Kearon, MB, PhD McMaster University
  More Information

Responsible Party: Hamilton Health Sciences Corporation
ClinicalTrials.gov Identifier: NCT01234064     History of Changes
Other Study ID Numbers: GCS Pilot Substudy
First Submitted: November 2, 2010
First Posted: November 4, 2010
Last Update Posted: January 18, 2012
Last Verified: December 2011

Keywords provided by McMaster University ( Hamilton Health Sciences Corporation ):
Symptomatic Venous Thromboembolism
Graduated Compression Stockings
Randomized Controlled Trial
Noncardiac Surgery

Additional relevant MeSH terms:
Thromboembolism
Venous Thromboembolism
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases