Clinical trial NCT01835990: Feasibility Study of Geko vs. IPCs in Trauma
Official title: Feasibility Study of a Randomized Controlled Trial of a Novel Device vs. Intermittent Pneumatic Compression for Prevention of Venous Thromboembolism in Trauma Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Trauma
Venous Thromboembolism
Keywords: venous thromboembolism
trauma
mechanical methods of prophylaxis
Lead sponsor: Hamilton Health Sciences Corporation
Sponsor class: OTHER
First posted: 2013-04-19
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: Feasibility of completing a larger, phase III trial with DVT incidence as primary outcome
timeFrame: earliest of when 40th subject is enrolled or 18 months from study start
Secondary outcomes:
measure: Compliance
timeFrame: Twice daily (excluding weekends and holidays), until subject exits study
measure: Development of venous thromboembolism
timeFrame: At time subject exits from study (day 10 or earlier)
measure: Tolerability
timeFrame: At time subject exits from study (day 10 or earlier)
measure: Venous and arterial physiological flow
timeFrame: At time subject exits from study (day 10 or earlier)
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: Hamilton General Hospital
state: Ontario
Study officials:
affiliation: McMaster University
name: Vinai C Bhagirath, MD FRCP(C)
role: PRINCIPAL_INVESTIGATOR
References: