Graduated Compression Stockings (GCS) Pilot Substudy

This study has been completed.
Sponsor:
Collaborators:
BSN Medical Inc
McMaster University
Information provided by (Responsible Party):
McMaster University ( Hamilton Health Sciences Corporation )
ClinicalTrials.gov Identifier:
NCT01234064
First received: November 2, 2010
Last updated: January 16, 2012
Last verified: December 2011

November 2, 2010
January 16, 2012
November 2010
December 2011   (final data collection date for primary outcome measure)
Objectively confirmed symptomatic major venous thromboembolism [ Time Frame: 30 days ] [ Designated as safety issue: No ]
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).
Same as current
Complete list of historical versions of study NCT01234064 on ClinicalTrials.gov Archive Site
  • Any symptomatic venous thromboembolism or pulmonary embolism [ Time Frame: 30 days ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Secondary outcomes to assess efficacy will include patients who, within 30 days, have major venous thromboembolism and death.
  • Safety Outcomes [ Time Frame: 30 Days ] [ Designated as safety issue: Yes ]
    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.
  • Any symptomatic venous thromboembolism or pulmonary embolism [ Time Frame: 30 days ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Secondary outcomes to assess efficacy will include patients who, within 30 days, have major venous thromboembolism and death.
  • Safety Outcomes [ Time Frame: 30 Days ] [ Designated as safety issue: Yes ]
    Harm from GCS 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.
Not Provided
Not Provided
 
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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment
Venous Thromboembolism
  • 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
  • Device: No Graduated Compression Stockings
    No stockings will be applied.
  • Active Comparator: Graduated Compression Stockings
    Intervention: Device: Anti-Embolism Graduated Pressure Stockings (by BSN-Jobst)
  • No Graduated Compression Stockings
    Intervention: Device: No Graduated Compression Stockings
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
50
December 2011
December 2011   (final data collection date for primary outcome measure)

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.
Both
45 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT01234064
GCS Pilot Substudy
No
McMaster University ( Hamilton Health Sciences Corporation )
Hamilton Health Sciences Corporation
  • BSN Medical Inc
  • McMaster University
Principal Investigator: Clive Kearon, MB, PhD McMaster University
McMaster University
December 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP