Feasibility Study of Geko vs. IPCs in Trauma

NCT01835990 | Completed Phase 2

• 1 other identifier: GIFT Pilot
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Keywords

venous thromboembolism; trauma; mechanical methods of prophylaxis

Outcome Measures

Primary Outcomes (1)

• Feasibility of completing a larger, phase III trial with DVT incidence as primary outcome

  This endpoint will be considered to have been met if, after enrollment of 40 subjects, both of the following conditions are met: i. the time from enrollment of the first subject to enrollment of the 40th subject is less than 18 months; AND ii. all secondary outcomes are evaluable for at least 80% of subjects.

  earliest of when 40th subject is enrolled or 18 months from study start

Secondary Outcomes (4)

• Compliance

  Twice daily (excluding weekends and holidays), until subject exits study

• Development of venous thromboembolism

  At time subject exits from study (day 10 or earlier)

• Tolerability

  At time subject exits from study (day 10 or earlier)

• Venous and arterial physiological flow

  At time subject exits from study (day 10 or earlier)

Study Arms (2)

geko

EXPERIMENTAL

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.

Device: geko

IPCs

ACTIVE COMPARATOR

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.

Device: IPCs

Interventions

geko 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.

Also known as: neuromuscular stimulation device

geko

IPCs DEVICE

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

Also known as: intermittent pneumatic compression devices, Arjo Huntleigh Flowtron

IPCs

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of trauma, meeting criteria for referral to the HHS trauma service - ANY of the following (1-3):
• patient with obvious major injuries in two or more systems, each requiring a specialist and inpatient care
• 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hamilton Health Sciences Corporation: lead

Study Sites (1)

Hamilton General Hospital

Hamilton, Ontario, L8L 2X2, Canada

Location

MeSH Terms

Conditions

Wounds and Injuries; Venous Thromboembolism

Interventions

Intermittent Pneumatic Compression Devices

Condition Hierarchy (Ancestors)

Thromboembolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Equipment and Supplies

Study Officials

• Vinai C Bhagirath, MD FRCP(C)

  McMaster University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 17, 2012
• First Posted: April 19, 2013
• Study Start: July 1, 2013
• Primary Completion: August 1, 2014
• Study Completion: August 1, 2014
• Last Updated: March 19, 2015

Record last verified: 2015-03

Locations

CA (1)