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.

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12611000424909

Enrollment

150

Registered

2011-04-27

Start date

2009-05-03

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief 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.

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 days). All patients will receive standard care consisting of early mobilization, graduated compression stockings and anticoagulant drugs as determined by their primary doctor.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Prevention

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

Patients undergoing spinal surgery, brain surgery, and patients with intracranial or subdural bleeding with paralysis

Exclusion criteria

leg ulceration, symptomatic peripheral neuropathy, symptomatic peripheral arterial disease, allergy to contrast medium, renal failure (GFR of less than 50mL/min)

Outcome results