Status:
COMPLETED
Feasibility Study of Geko vs. IPCs in Trauma
Lead Sponsor:
Hamilton Health Sciences Corporation
Conditions:
Trauma
Venous Thromboembolism
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
July 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2014
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT01835990
Start Date
July 1 2013
End Date
August 1 2014
Last Update
March 19 2015
Active Locations (1)
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1
Hamilton General Hospital
Hamilton, Ontario, Canada, L8L 2X2