ISRCTN52566874已完成不适用
Activated protein C versus placebo in the treatment of INFlammatory or infectious Acute Lung Injury/acute respiratory distress syndrome (INFALI): a pathophysiological study on pulmonary microvascular permeability, apoptosis, inflammation and coagulatio
Vrije University Medical Center (VUMC) (The Netherlands)0 个研究点目标入组 106 人开始时间: 2006年11月22日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 106
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1. Age 18 to 75 years
- •2. Weight less than 135 kg
- •3. Recent onset (less than 24 hours) of ALI/ARDS, according to the American/European consensus criteria
- •4. ALI/ARDS due to severe sepsis reflecting single organ failure
排除标准
- •1. Acute Physiology And Chronic Health Evaluation (APACHE II) score: 25 and more
- •2. Two or more failing organs
- •3. Thrombocyte count less than 30 x 10^9/l
- •4. Any major surgery within 12 hours before inclusion
- •5. Trauma patients at increased risk of bleeding
- •6. Acute bleeding
- •7. A history of severe head trauma that required hospitalisation, intracranial surgery, or stroke within three months of study entry
- •8. Known intracranial abnormality such as aneurysms, tumor, arterio-venous malformation
- •9. Known hypercoagulability:
- •9.1. Resistance to protein C
- •9.2. Hereditary deficiency of protein C, protein S, or anti-thrombin
- •9.3. Presence of anticardiolipin antibody, antiphospholipid antibody, lupus anticoagulant or homocystinaemia
- •9.4. Recently documented (within three months of study entry) or highly suspected deep vein thrombosis or pulmonary embolism
- •10. A history of congenital bleeding diasthesis
- •11. Expected life expectancy less than 28 days (moribund state)
- •12. Preterminal illness
- •13. Pregnancy or breast feeding
- •14. Known portal hypertension with liver cirrhosis, oesophageal varices or both
- •15. Epidural catheter
- •16. Body weight more than 135 kg
- •17. Chronic renal insufficiency
- •18. Participation in another clinical trial
- •19. Patients with immune system impairment:
- •19.1. Human immunodeficiency virus (HIV)-infected patients (CD4+ less than 50/ml)
- •19.2. After bone-marrow, lung, liver, pancreas or small-bowel transplantation and treated with immunosuppressive therapy
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