A randomised controlled trial to evaluate whether use of intrapleural urokinase aids the drainage of multi-septated pleural effusion compared to placebo

Phase 3

Completed

• Conditions: Malignant pleural effusions; Cancer; Pleural effusion, not elsewhere classified

• Registration Number: ISRCTN12852177
• Lead Sponsor: niversity of Oxford (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-06-05
• Last Update Posted: 9 October 2017

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 71

Inclusion Criteria

1. Both males and females
2. A clinically confident diagnosis of pleural malignancy defined as:
2.1 Histocytologically proven pleural malignancy, or
2.2. Otherwise unexplained exudative pleural effusion in the context of histocytologically proven cancer elsewhere
2. A significant (>25% hemithorax area) multi-loculated or multi-septated pleural effusion (residual effusion on chest radiograph despite the presence of a patent in-situ chest tube)
3. Malignant pleural effusion requiring drainage and pleurodesis for symptom control
4. Written informed consent

Exclusion Criteria

1. Age <18 years
2. Expected survival <28 days
3. Previous pneumonectomy on the side of the effusion
4. Positive ipsilateral pleural fluid gram stain or bacterial culture in the previous month
5. Previously received intra-pleural fibrinolytic agents into this effusion
6. Known sensitivity to urokinase
7. Coincidental stroke, major haemorrhage or major trauma
8. Major surgery in the previous 5 days
9. Chylothorax
10. Total blood white cell count <1.0 x 10^9
11. Patients who are pregnant or lactating
12. Irreversible bleeding diathesis or platelet count <100 x 10^9
13. Irreversible visual impairment
14. Inability to give informed consent or comply with the protocol

Study & Design

• Study Type: Interventional
• Study Design: Not specified