Feasibility Study of a Randomized Controlled Trial of a Novel Device vs. Intermittent Pneumatic Compression for Prevention of Venous Thromboembolism in Trauma Patients
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Feasibility of completing a larger, phase III trial with DVT incidence as primary outcome
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
- •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
结局指标
主要结局
Feasibility of completing a larger, phase III trial with DVT incidence as primary outcome
时间窗: earliest of when 40th subject is enrolled or 18 months from study start
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.
次要结局
- 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))