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临床试验/NCT00524147
NCT00524147已完成不适用

Drainage of Tuberculous Pleural Effusions

Taipei Medical University Hospital1 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2003年10月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
64
试验地点
1
主要终点
Chest radiography, daily monitoring of the volume of fluid drained, the time needed for resolution of fever and dyspnea, and total amounts of fluid drained, and the length of chest drainage and hospitalization

研究概览

简要总结

Tuberculous (TB) pleurisy can cause clinical symptoms and pleural fibrosis with resultant residual pleural thickening (RPT). Therapeutic thoracentesis or initial complete drainage in addition to anti-TB drugs have been tried to rapidly relieve dyspnea caused by effusion and to decrease the occurrence of RPT. However, contradictory results are reported without clear reasons. The researchers' hypothesis is that, in addition to anti-TB medications, early effective evacuation of inflammatory exudates with or without fibrinolytic agents may hasten resolution of pleural effusion, reduce the occurrence of RPT and finally improve long-term functional outcome in patients with TB pleurisy.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
16 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Diagnosis of tuberculous pleurisy

排除标准

  • History of invasive procedures directed into the pleural cavity
  • Recent severe trauma, hemorrhage, or stroke; bleeding disorder or anticoagulant therapy
  • Use of streptokinase in the previous 2 years
  • Lack of clinical symptoms caused by effusions

结局指标

主要结局

Chest radiography, daily monitoring of the volume of fluid drained, the time needed for resolution of fever and dyspnea, and total amounts of fluid drained, and the length of chest drainage and hospitalization

时间窗: baseline, daily after treatment within admission

次要结局

  • Chest radiography and pulmonary function testing with spirometry(At discharge and at 2, 4, 6, and 12 months)

研究者

申办方类型
Other

研究点 (1)

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