CompletedPhase 2Phase 3ACTRN12611000424909

Randomized controlled trial of a new light weight battery operated calf compression device (Venowave) for prevention of venous thrombosis.

Open label randomized controlled trial of a new calf compression device (venowave) versus no Venowave device on background of standard care for prevention of venous thromboembolism in patients undergoing neurosurgery.


Sponsor

Hamilton Health Sciences

Enrollment

150 participants

Start Date

May 3, 2009

Study Type

Interventional

Conditions

Summary

The main purpose of the study is to establish if addition of Venowave devices to standard care in neurosurgical inpatients reduces the risk of venous thrombosis. We also aim to establish if the device is safe and well tolerated by patients.


Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

This trial tests a lightweight, battery-operated calf compression device called Venowave for preventing blood clots in the legs after brain or spinal surgery. Adults aged 18+ undergoing these surgeries are eligible, except those with leg ulcers, peripheral artery disease, kidney failure, or contrast dye allergies.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

Bilateral calf compression devices (Venowave) will be applied within 4 hours of surgery completion and will be continued for up to 24 hours per day (maximum tolerated) for study duration (7 days +/- 2

Bilateral calf compression devices (Venowave) will be applied within 4 hours of surgery completion and will be continued for up to 24 hours per day (maximum tolerated) for study duration (7 days +/- 2 days). All patients will receive standard care consisting of early mobilization, graduated compression stockings and anticoagulant drugs as determined by their primary doctor.


Locations(1)

Ontario, Canada

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ACTRN12611000424909