Graduated Compression Stockings (GCS) Pilot Substudy

Venous Thromboembolism Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01234064
• Other study ID #: GCS Pilot Substudy
• Status: Completed
• Phase: Phase 3
• First received: November 2, 2010
• Last updated: January 16, 2012
• Start date: November 2010
• Est. completion date: December 2011

Study information

• Verified date: December 2011
• Source: McMaster University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 45 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Thromboembolism
• Venous Thromboembolism

Intervention

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.
• No Graduated Compression Stockings
No stockings will be applied.

Locations

Country	Name	City	State
Canada	Henderson Hospital	Hamilton	Ontario

Sponsors (3)

Lead Sponsor	Collaborator
Hamilton Health Sciences Corporation	BSN Medical Inc, McMaster University

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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.	30 days	No
Secondary	Major venous thromboembolism and death	Secondary outcomes to assess efficacy will include patients who, within 30 days, have major venous thromboembolism and death.	30 Days	No
Secondary	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.	30 Days	Yes