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

Date de début de l'étude : 1 juillet 2013

Inclusion Criteria: 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 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