Graduated Compression Stockings (GCS) Pilot Substudy

NCT ID: NCT01234064

Last Updated: 2012-01-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-11-30

Study Completion Date

2011-12-31

Brief Summary

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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

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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.

Conditions

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Venous Thromboembolism

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Graduated Compression Stockings

Group Type ACTIVE_COMPARATOR

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

Intervention Type DEVICE

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

No Graduated Compression Stockings

Group Type OTHER

No Graduated Compression Stockings

Intervention Type DEVICE

No stockings will be applied.

Interventions

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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.

Intervention Type DEVICE

No Graduated Compression Stockings

No stockings will be applied.

Intervention Type DEVICE

Other Intervention Names

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Anti-Em/GP

Eligibility Criteria

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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.
Minimum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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BSN Medical Inc

INDUSTRY

Sponsor Role collaborator

McMaster University

OTHER

Sponsor Role collaborator

Hamilton Health Sciences Corporation

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clive Kearon, MB, PhD

Role: PRINCIPAL_INVESTIGATOR

McMaster University

Locations

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Henderson Hospital

Hamilton, Ontario, Canada

Site Status

Countries

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Canada

Other Identifiers

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GCS Pilot Substudy

Identifier Type: -

Identifier Source: org_study_id

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