NCT01835990

Feasibility Study of Geko vs. IPCs in Trauma

Feasibility Study of a Randomized Controlled Trial of a Novel Device vs. Intermittent Pneumatic Compression for Prevention of Venous Thromboembolism in Trauma Patients

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Hamilton Health Sciences Corporation · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Trauma patients are at a high risk of developing blood clots in the legs (deep vein thrombosis - DVT), which can travel to the lungs and cause serious health consequences. Often, these patients cannot receive blood-thinning medication to prevent these blood clots because of the risk of bleeding; in this case, they are usually given intermittent pneumatic compression devices (IPCs) to prevent blood clots. IPCs are inflatable sleeves that fit over the legs and periodically inflate and deflate, helping to pump blood out of the legs and thus reduce the risk of blood clot formation. Several studies suggest that IPCs are working properly on the patient only 60-70% of the time. Some patients also find them uncomfortable. A new device (geko) that works by stimulating the leg muscles and increasing blood flow in the legs has recently been developed. To compare the geko with IPCs, this study will randomly assign trauma patients who cannot receive blood thinners for blood clot prevention to either IPCs or geko. The main goal is to determine the feasibility of doing a larger study which would compare the efficacy of these devices in preventing blood clots. The amount of time the devices are properly used on the patients, comfort and tolerability, development of blood clots, and blood flow in the leg veins and arteries will also be measured and compared between the devices.

Conditions

• Trauma
• Venous Thromboembolism

Interventions

Type	Name	Description
DEVICE	geko	The geko is a neuromuscular stimulation device that stimulates the common peroneal nerve resulting in contraction of the leg muscles and increased venous and arterial flow. It is Health Canada approved for prevention of deep venous thrombosis.
DEVICE	IPCs	devices that pneumatically compress the leg, resulting in increased venous blood flow.

Timeline

• Start date: 2013-07-01
• Primary completion: 2014-08-01
• Completion: 2014-08-01
• First posted: 2013-04-19
• Last updated: 2015-03-19

Locations

1 site across 1 country: Canada