EUCTR2009-012387-13-GB进行中（未招募）不适用
PROTECT - Prophylaxis of ThromboEmbolism in Critical Care Trial - PROTECT
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 3,650
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Inclusion Criteria:
- •1.Men or women >18 years of age
- •2. Actual body weight >45 kg
- •3.Admission to intensive care unit expected to be >72 hours duration
- •4. Eligible for either unfractionated heparin or low molecular weight heparin thromboprophylaxis
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Contraindication to prophylactic heparin
- •1.Neurosurgery within last 3 months
- •2.Ischemic or hemorrhagic stroke within last 3 months
- •3.Intracranial hemorrhage, within last 3 months
- •4.Systolic blood pressure > 180 mmHg, diastolic blood pressure > 110 mmHg for > 12 hours requiring vasoactive drug infusion
- •5.Major hemorrhage within the last week unless definitively treated
- •6.Coagulopathy (INR > 2 x ULN, or PTT > 2 x ULN)
- •7.Thrombocytopenia
- •8. Other heparin contraindications (e.g., HIT, pregnancy)
- •9.Contraindications to blood products (e.g., Jehovah’s Witness)
- •10.Unable to perform lower limb ultrasound (e.g., severe distal extremity burns)
- •11. Limitation of life support (life expectancy < 7 days, or palliative care
- •12.Contamination (e.g., > 3 days of any heparin prophylaxis during this ICU admission)
- •13.Patient or substitute decision maker (SDM) declines consent
- •14.Patient unable to give consent and no SDM available
- •15.Randomized previously in PROTECT or related RCT
研究者
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