Feasibility Study of Geko vs. IPCs in Trauma

NCT ID: NCT01835990

Last Updated: 2015-03-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-07-31
• Study Completion Date: 2014-08-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

geko

For subjects randomized to the experimental treatment arm, one gekoTM device will be applied to each leg according to the manufacturer's instructions by the subject's primary care nurse. All nurses applying the devices must be trained on proper application technique. The old devices will be removed and new devices applied daily. The subject will continue to use the devices until he or she exits the study.

Group Type: EXPERIMENTAL

geko

Intervention Type: DEVICE

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.

IPCs

The control treatment will consist of the hospital's standard IPC devices. The IPCs will be applied to each leg by the subject's primary care nurse according to the manufacturer's instructions. They will continue to be applied until exit from the study. At the time of withdrawal from the study, the decision regarding continued use of IPCs will be made by the treating physician.

Group Type: ACTIVE_COMPARATOR

IPCs

Intervention Type: DEVICE

devices that pneumatically compress the leg, resulting in increased venous blood flow.

Interventions

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.

Intervention Type: DEVICE

IPCs

devices that pneumatically compress the leg, resulting in increased venous blood flow.

Intervention Type: DEVICE

Other Intervention Names

neuromuscular stimulation device; intermittent pneumatic compression devices; Arjo Huntleigh Flowtron

Eligibility Criteria

Inclusion Criteria

• Diagnosis of trauma, meeting criteria for referral to the HHS trauma service - ANY of the following (1-3):

1. patient with obvious major injuries in two or more systems, each requiring a specialist and inpatient care

2. spinal injury with paraplegia or tetraplegia; severe penetrating injury to the head, neck, trunk or groin; amputation above the wrist or ankle; burns, second or third degree, involving 20% or more body surface area, or involving the face or genitalia

3. Glasgow Coma Scale (GCS) less than or equal to 10, as a result of trauma or any two of:

• significant decrease in level of consciousness
• pulse < 50 or > 120
• BP < 80 or absent radial pulse
• Respiratory rate < 10 or > 24
• Subject admitted to the Hamilton General Hospital ICU or the hospital ward step-down units
• Age 18 years or older
• Contraindication to anticoagulation expected to last for more than 3 days. Contraindication to anticoagulation may include intracranial hemorrhage, ocular injury with associated hemorrhage, solid intra-abdominal organ injury (i.e. liver, spleen, kidney), and/or pelvic or retroperitoneal hematoma requiring transfusion. [12] The final determination of whether anticoagulant prophylaxis is contraindicated will be made by the treating physician.
• Projected hospitalization greater than 3 days (as determined by treating physician)
• Informed consent can be provided by the subject or substitute decision maker within 48 hours of admission

Exclusion Criteria

• Inability to wear either IPCs or gekoTM on both legs, including but not limited to:

• unstable fracture of the lower extremity;
• compartment syndrome of the lower extremity;
• skin breakdown affecting the area on which the devices will be applied;
• prior amputation affecting the area on which the devices will be applied;
• severe peripheral ischemic vascular disease;
• uncontrolled bleeding of the lower extremity;
• Diagnosis of DVT within 1 month prior to assessment for enrollment
• Use of anticoagulant medication within 24h of enrollment (except when used solely as a flush for intravenous catheters), or ongoing effect of anticoagulant medication at time of enrollment as determined by history of medication use and laboratory evidence of medication effect. For the purposes of this study, anticoagulant medications include:

• unfractionated heparin (intravenous or subcutaneous)
• low molecular weight heparin
• fondaparinux
• dabigatran
• rivaroxaban
• warfarin
• argatroban
• danaparoid
• lepirudin
• Leg circumference greater than 24 inches at the location the gekoTM device would be secured to the leg.
• Presence of cardiac demand pacemaker

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hamilton Health Sciences Corporation

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Vinai C Bhagirath, MD FRCP(C)

Role: PRINCIPAL_INVESTIGATOR

McMaster University

Locations

Hamilton General Hospital

Hamilton, Ontario, Canada

Countries

Canada

Other Identifiers

GIFT Pilot

Identifier Type: -

Identifier Source: org_study_id