PROphylaxis for ThromboEmbolism in Critical Care Trial (PROTECT)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 3,659
- 试验地点
- 67
- 主要终点
- To evaluate the effect of LMWH (Fragmin, dalteparin) versus UFH on the primary outcome of proximal leg DVT diagnosed by compression ultrasound
研究概览
简要总结
The purpose of this study is to evaluate the effect of Low Molecular Weight Heparin (LMWH) (Fragmin, dalteparin) versus Unfractionated Heparin (UFH) on the primary outcome of proximal leg Deep Vein Thrombosis (DVT) diagnosed by compression ultrasound, and the secondary outcomes of Pulmonary Embolism (PE), bleeding, Heparin-Induced Thrombocytopenia (HIT), and objectively confirmed venous thrombosis at any site.
详细描述
PROTECT: The PROphylaxis for ThromboEmbolism in Critical Care Trial.
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. 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 randomized trial (n=119) in medical-surgical ICU patients demonstrates that unfractionated heparin (UFH) prevents DVT compared to no prophylaxis; only 1 randomized trial (n=223) in ventilated COPD patients shows that low molecular weight heparin (LMWH) prevents DVT compared to no prophylaxis. In medical-surgical ICUs, the effect of LMWH vs UFH for DVT prevention has not been tested. On one hand, LMWH is likely to be more effective at venous thromboembolism (VTE) prevention and is associated with a lower rate of heparin-induced thrombocytopenia (HIT). On the other hand, UFH is likely associated with less bleeding, and is less expensive. Current guidelines indicate that in the absence of comparative data, both LMWH and UFH are suitable for thromboprophylaxis in this population, but that a randomized trial is needed.
PROTECT Pilot: In our Pilot Study, feasibility objectives were to assess:
- timely enrolment and complete, blinded study drug administration, 2) the bioaccumulation of LMWH in patients with acquired renal insufficiency, 3) twice weekly leg ultrasounds, and 4) recruitment rates.
- Timely, complete administration occurred for 98% of scheduled doses; every dose was blinded.
- No LWMH bioaccumulation was observed.
- Scheduled ultrasounds occurred without exception.
- Recruitment will be 4 patients/month/centre after modification of 3 exclusion criteria in the PROTECT pilot.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Patient is >/= 18 years of age
- •Actual body weight is >/= 45 kg
- •Admission to ICU expected to be >/= 72 hours in duration
排除标准
- •Neurosurgery within last 3 months
- •Ischemic stroke within last 3 months
- •Intracranial hemorrhage within last 3 months
- •Systolic Blood Pressure >/= 180mm Hg, Diastolic Blood Pressure >/= 110mm Hg for >/= 12 hours requiring vasoactive drug infusion
- •Major hemorrhage within last week unless definitively treated
- •Coagulopathy as defined by INR >/= 2 times upper limit of normal [ULN], or PTT >/= 2 times ULN, at time of screening
- •Thrombocytopenia defined as platelet count </= 75 x 109/L, at time of screening
- •Other heparin contraindications (e.g., HIT, pregnancy, lactating)
- •Contraindication to blood products (e.g., Jehovah's Witness)
- •Unable to perform lower limb ultrasound (e.g., bilateral above the knee amputation, or severe distal extremity burns)
- •Limitation of life support, Life expectancy </= 14 days, or palliative care
- •Contamination (e.g., >/= 3 doses of LMWH during this ICU admission)
- •Lack of informed consent
研究组 & 干预措施
LMWH (Fragmin, dalteparin)
Placebo dose (normal saline) = AM dose LMWH (Fragmin, dalteparin) 5000IU daily = PM dose
干预措施: LMWH (Fragmin, dalteparin) (Drug)
2
Unfractionated Heparin 5000IU BID
干预措施: Unfractionated Heparin (Drug)
结局指标
主要结局
To evaluate the effect of LMWH (Fragmin, dalteparin) versus UFH on the primary outcome of proximal leg DVT diagnosed by compression ultrasound
时间窗: While in ICU to a maximum of 90 days
次要结局
- To evaluate the effect of LMWH (Fragmin, dalteparin) versus UFH on the secondary outcomes of PE, bleeding, HIT, and objectively confirmed venous thrombosis at any site(While in ICU to a maximum of 90 days)