Drainage of Tuberculous Pleural Effusions
1 other identifier
interventional
64
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Oct 2003
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2006
CompletedFirst Submitted
Initial submission to the registry
August 31, 2007
CompletedFirst Posted
Study publicly available on registry
September 3, 2007
CompletedDecember 30, 2010
December 1, 2010
2 years
August 31, 2007
December 28, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
baseline, daily after treatment within admission
Secondary Outcomes (1)
Chest radiography and pulmonary function testing with spirometry
At discharge and at 2, 4, 6, and 12 months
Interventions
Eligibility Criteria
You may qualify if:
- Diagnosis of tuberculous pleurisy
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Taipei Medical University Hospital
Taipei, Taiwan
Related Publications (1)
Chung CL, Chen CH, Yeh CY, Sheu JR, Chang SC. Early effective drainage in the treatment of loculated tuberculous pleurisy. Eur Respir J. 2008 Jun;31(6):1261-7. doi: 10.1183/09031936.00122207. Epub 2008 Jan 23.
PMID: 18216051DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Chi-Li Chung, MD
Department of Internal Medicine, Taipei Medical University Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
August 31, 2007
First Posted
September 3, 2007
Study Start
October 1, 2003
Primary Completion
October 1, 2005
Study Completion
December 1, 2006
Last Updated
December 30, 2010
Record last verified: 2010-12