PROphylaxis for ThromboEmbolism in Critical Care Trial (PROTECT Pilot)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 32
- 主要终点
- The primary outcome for the PROTECT Study is objectively confirmed proximal DVT (proven symptomatic or asymptomatic DVT) diagnosed by bilateral lower extremity compression ultrasound, confirmed by venography when possible.
研究概览
简要总结
PROTECT Pilot objective is to assess: 1) the feasibility of timely enrollment and complete, blinded study drug administration, 2) the bioaccumulation of LMWH in patients with acquired renal insufficiency and its association with bleeding, 3) the feasibility of scheduled twice weekly lower limb ultrasounds, and 4) recruitment rates for a future randomized trial.
详细描述
Prophylaxis for Thromboembolism in Critical Care Trial:
PROTECT pilot Study
Background: Critically ill patients have an increased risk of deep venous thrombosis (DVT) due to their acute illness, procedures such as central venous catheterization, and immobility due to sedation and paralysis. Among patients in the intensive care unit (ICU), DVT is an important problem, since thrombus propagation and embolization can lead to potentially fatal pulmonary embolism (PE). Only 1 published randomized trial (n=119) in medical-surgical ICU patients demonstrates that unfractionated heparin (UFH) prevents DVT as compared to no prophylaxis; only 1 published randomized trial (n=223) in mechanically ventilated COPD patients shows that low molecular weight heparin (LMWH) prevents DVT as compared to no prophylaxis. A trial comparing LMWH and UFH for DVT prophylaxis in medical-surgical ICU patients is needed. On one hand, LMWH is likely to be more effective at VTE prevention and is associated with a lower rate of heparin-induced thrombocytopenia (HIT). On the other hand, UFH is likely to be associated with a lower bleeding rate, and is less expensive. The necessity for such a trial is highlighted by the fact that UFH is the dominant method of VTE prophylaxis in critically ill patients in Canada, whereas LMWH is standard of practice in western Europe.
Objectives: The scientific objectives of PROTECT are to determine the effect of LMWH versus UFH on rates of DVT, PE, bleeding, thrombocytopenia and HIT in medical-surgical ICU patients. The feasibility objectives of the PROTECT Pilot are to assess: 1) the feasibility of timely enrollment and complete, blinded study drug administration, 2) the bioaccumulation of LMWH in patients with acquired renal insufficiency and its association with bleeding, 3) the feasibility of scheduled twice weekly lower limb ultrasounds, and 4) recruitment rates for a future randomized trial.
Design: Prospective, concealed, stratified, block randomized, blinded, multicentre trial.
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
- Double
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
- •Admission to ICU
- •Men and women greater than 18 years of age or older
- •Expected to remain in ICU admission greater than 72 hours
排除标准
- •Contraindications to LMWH or blood products
- •Trauma, post orthopedic surgery, post cardiac surgery or post neurosurgery patients,
- •Uncontrolled hypertension as defined by a systolic blood pressure > 180 mmHg or a diastolic blood pressure > 110 mmHg,
- •Hemorrhagic stroke, DVT, PE or major hemorrhage on admission or within 3 months,
- •Coagulopathy as defined by INR >2 times upper limit of normal [ULN], or PTT >2 times ULN,
- •Renal insufficiency as defined by a creatinine clearance <30ml/min,
- •A need for oral or intravenous or subcutaneous therapeutic anticoagulation,
- •Heparin allergy, proven or suspected heparin-induced thrombocytopenia (HIT),
- •Receipt of >2 doses of UFH or LMWH in ICU,
- •Pregnant or lactating,
- •Withdrawal of life support or limitation of life support,
- •Prior enrollment in this trial
- •Prior enrollment into a related RCT
- •Thrombocytopenia defined platelet count < 100 x 109/L,
- •Bilateral lower limb amputation,
- •Allergy to pork or pork products
结局指标
主要结局
The primary outcome for the PROTECT Study is objectively confirmed proximal DVT (proven symptomatic or asymptomatic DVT) diagnosed by bilateral lower extremity compression ultrasound, confirmed by venography when possible.
次要结局
- There are four secondary outcomes: 1) PE diagnosed by the PE Diagnosis algorithm, 2) bleeding, 3) anti-Xa levels associated with heparin dose adjustment, 4) thrombocytopenia and HIT