Graduated Compression Stockings (GCS) Pilot Substudy

NCT01234064 | Completed Phase 3

• 1 other identifier: GCS Pilot Substudy
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Venous Thromboembolism

Keywords

Symptomatic Venous Thromboembolism; Graduated Compression Stockings; Randomized Controlled Trial; Noncardiac Surgery

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Any symptomatic venous thromboembolism or pulmonary embolism

  30 days

• Major venous thromboembolism and death

  30 Days

• Safety Outcomes

  30 Days

Study Arms (2)

Graduated Compression Stockings

ACTIVE COMPARATOR

Device: Anti-Embolism Graduated Pressure Stockings (by BSN-Jobst)

No Graduated Compression Stockings

OTHER

Device: No Graduated Compression Stockings

Interventions

Anti-Embolism Graduated Pressure Stockings (by BSN-Jobst) DEVICE

Apply 2 to 4 hours prior to surgery. Patient will continue to wear stockings until post-op Day 10.

Also known as: Anti-Em/GP

Graduated Compression Stockings

No Graduated Compression Stockings DEVICE

No stockings will be applied.

No Graduated Compression Stockings

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hamilton Health Sciences Corporation: lead
• BSN Medical Inc: collaborator
• McMaster University: collaborator

Study Sites (1)

Henderson Hospital

Hamilton, Ontario, Canada

Location

MeSH Terms

Conditions

Venous Thromboembolism

Condition Hierarchy (Ancestors)

Thromboembolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Clive Kearon, MB, PhD

  McMaster University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 2, 2010
• First Posted: November 4, 2010
• Study Start: November 1, 2010
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: January 18, 2012

Record last verified: 2011-12

Locations

CA (1)