ACTRN12616001442493终止1 期
Phase 1a/1b Trial of LTI-01 (Single Chain Urokinase, scuPA) Intrapleural Fibrinolytic Therapy (IPFT) in Patients with Complicated Parapneumonic Effusions or Empyema
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 21
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 21 Years 至 o limit（—）
- 性别
- All
入选标准
- •1. Male or female greater than or equal to 21 years of age
- •2. A clinical presentation compatible with pneumonia and a parapneumonic effusion
- •3. Has pleural fluid requiring drainage that is loculated as determined by lateral decubitius or chest CT or by chest ultrasonography, and which is either:
- •* purulent or
- •* gram stain positive or
- •* culture positive or
- •* acidic with a pH <=7.2 or
- •* greater than half the volume of the thoracic cavity
- •4. Written informed consent
- •5. Failure to drain the pleural space within 3 h after tube thoracostomy
- •6. Hemodynamically stable and not requiring use of intravenous pressor therapy
- •7. Absence of severe metabolic derangements such as a serum potassium of <6 mEq/L or diabetic ketoacidosis
排除标准
- •1. Previous treatment with intra-pleural fibrinolytics for this CPE/empyema
- •2. Has a known sensitivity to urokinase plasminogen activator
- •3. Has had a coincidental stroke, a major hemorrhage or major trauma
- •4. Head trauma or previous stroke
- •5. History of previous intracranial hemorrhage or symptoms suggestive of possible current intracranial hemorrhage.
- •6. Vascular puncture at a non-compressible site in the previous 7 days (e.g. subclavian artery, subclavian vein or internal jugular puncture)
- •7. Elevated blood pressure (systolic >185 mm Hg) or diastolic mm Hg (>110)
- •8. Active bleeding on examination
- •9. Acute bleeding diathesis: platelets <100,000 mm3 or therapeutic doses of heparin received within 48h or history of current warfarin therapy; use of other oral anticoagulants including warfarin or Xa or thrombin inhibitors.
- •10. Known platelet functional disorder or use of antiplatelet therapy including clopidigrel or other antiplatelet agents other than aspirin at any dose.
- •11. Estimated creatinine clearance of <30 ml/minute or estimated GFR (glomerular filtration rate)<30 ml/minute.
- •12. PT/PTT> 1.7x control or PT>15 sec.
- •13. Has had major surgery in the previous 10 days
- •14. Has had a previous pneumonectomy on the side of infection
- •15. Patients who are pregnant or lactating (females of childbearing potential must have a negative pregnancy test before randomization)
- •16. Expected survival less than three months from a different pathology to this empyema (e.g. metastatic lung carcinoma)
- •17. Known prior ipsilateral fibrothorax
- •18. Plasma fibrinogen (FGN) level < 150 mg/L
- •19. Known allergy to rodents
研究者
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