ISRCTN44653506已完成未知
Prophylaxis of thromboembolism in critically ill patients using combined intermittent pneumatic compression and pharmacologic prophylaxis versus pharmacologic prophylaxis alone: a multicenter randomized controlled trial
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 2,003
研究概览
简要总结
2016 Protocol article in http://www.ncbi.nlm.nih.gov/pubmed/27488380 protocol 2019 Results article in https://www.ncbi.nlm.nih.gov/pubmed/30779530 results 2020 Results article in https://www.ncbi.nlm.nih.gov/pubmed/32095845 sub-study results (added 26/02/2020) 2022 Results article in https://pubmed.ncbi.nlm.nih.gov/35595804/ Secondary analysis (added 23/05/2022) 2023 Other publications in https://pubmed.ncbi.nlm.nih.gov/36869382/ Post hoc analysis (added 06/03/2023)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •All patients (male + female) admitted to ICU will be screened for eligibility
- •1. Medical-Surgical ICU patients >14 years old
- •2. Weight > 45 kg
- •3. Expected ICU LOS> 72 hours
- •4. Eligible for pharmacologic thromboprophylaxis with UFH and LMWH
排除标准
- •Exclusion criteria as of 04/04/2017:
- •1. Patient treated with IPC for > 24 hours in this current ICU admission.
- •2. Patient in the ICU> 48 hours.
- •3. Patient treated with pharmacologic VTE prophylaxis with medications other than UFH or LMWH.
- •4. Inability or contraindication to applying IPC to both legs or to obtain adequate ultrasound on the lower extremities
- •4.1. Burns in the lower extremities, lacerations, active skin infection, & ischemic limb in the legs, large dressings at the site of IPC placement or in the thighs that prevent adequate ultrasounds
- •4.2. Acute ischemia in the lower extremities
- •4.3. Amputated foot or leg on one or two sides
- •4.4. Compartment Syndrome
- •4.5. Severe peripheral arterial disease
- •4.6. Vein ligation, gangrene, recent vein grafts, and draining incisions
- •4.7. Evidence of bone fracture in lower extremities
- •4.8. Arterial lines in the dorsalis pedis artery
- •5. Therapeutic dose of anticoagulation with UFH or LMWH
- •6. Pregnancy
- •7. Limitation of life support, life expectancy < 7 days or palliative care
- •8. Allergy to the sleeves material
- •9. Patients with Inferior Vena Cava (IVC) Filter
- •Eligible Non-Randomized Criteria
- •1. Patient or substitute decision maker declines consent but agrees to minimal data set collection
- •2. Unable to get consent within 48 hours of ICU admission
- •3. ICU physician or other treating clinician declines consent
- •4. Co-enrollment in trials with biologic interaction
- •Original exclusion criteria:
- •1. Patient on IPC for > 24 hours in this current ICU admission
- •2. Patient on pharmacologic prophylaxis with medications other than UFH or LMWH
- •3. Inability or contraindication to applying IPC to both legs:
- •3.1. Burns in the lower extremities, lacerations, active skin infection, & ischemic limb in the legs at the site of IPC placement
- •3.2. Acute ischemia in the lower extremities
- •3.3. Amputated foot or leg on one or two sides
- •3.4. Compartment Syndrome
- •3.5. Severe peripheral arterial disease
- •3.6. Vein ligation, gangrene, recent vein grafts, and draining incisions
- •3.7. Evidence of bone fracture in lower extremities
- •4. The need for therapeutic anticoagulation
- •5. Pregnancy
- •6. Limitation of life support, life expectancy < 7 days or palliative care
- •7. Allergy to the sleeves material
研究者
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