ISRCTN43849290已完成未知
Dose-finding and safety of heparin aerosol application in idiopathic pulmonary fibrosis
Individual Sponsor (Germany)0 个研究点目标入组 19 人开始时间: 2006年4月28日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 19
研究概览
简要总结
2010 results in: https://www.ncbi.nlm.nih.gov/pubmed/20109123 (added 03/05/2019)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Patients with idiopathic pulmonary fibrosis (IPF) according to consensus criteria
- •2. Age between 18 and 70
- •3. Completion of physical examination
- •4. Body weight of more than 40 kg
- •5. 40% < forced vital capacity (FVC) < 90%
- •6. 30% < diffusing capacity of the lung for carbon monoxide (Dlco) < 75%
- •7. Capillary pO2 >55 mmHg (with or without O2)
- •8. Signed informed consent
- •9. Requirements of Local Ethics Committee are met
排除标准
- •1. Any hemoptysis of unknown reason
- •2. Any significant and otherwise unexplainable bleeding with reduction of hemoglobin values by more than 10% in patient’s history
- •3. Pre-existing presence of heparin induced antibodies
- •4. Preceding surgery within last 6 weeks
- •5. Current gastric or duodenal ulcer or inflammatory bowel disease
- •6. Any oesophageal varicosis of any size
- •7. Current colon adenoma with previous gastrointestinal bleeding
- •8. Current lower respiratory tract infection with CRP >10 mg/l
- •9. Any suspected or proven active malignancy, especially lung cancer
- •10. Any need for systemic anticoagulation with International Normalized Ratio (INR) >1.5
- •11. Any treatment with another investigational drug
- •12. Acute or chronic left heart failure
- •13. Severe arterial hypertension (>200 mmHg systolic or >120 mmHg diastolic)
- •14. Inherited or acquired coagulation disorders resulting in prolonged bleeding time or an INR >1.5
- •15. Disseminated intravascular coagulation
- •16. Deficient thrombocyte function or platelet counts <40,000 /µl
- •17. Evidence for intracranial hemorrhage
- •18. Diabetic retinopathy
- •19. Severe hepatic insufficiency (bilirubin >10 mg%)
- •20. Renal insufficiency with creatinine values >3mg% or proteinuria >1 g per day
- •21. Primary or secondary immunodeficiency
- •22. Previous therapeutic radiation of the lungs or the mediastinum
- •23. Elevated intracranial pressure
- •24. Pregnancy, breast feading or lack of safe contraception
- •25. Patients whose underlying disease is not likely to permit them to survive the study - any hemoptysis of unknown reason
- •26. Sickle cell anemia
研究者
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