Randomized Controlled Trial of Urokinase versus Placebo for Nondraining Malignant Pleural Effusion

• DOI: 10.1164/rccm.201704-0809oc
• Publication Date: 2017-09-19T20:15:53Z
• Authors: Eleanor K. Mishra; Amelia O. Clive; Genevieve H. Wills; Helen E. Davies; Andrew E. Stanton; Mohamed Al-Aloul; Alan Hart-Thomas; Justin Pepperell; Matthew Evison; Tarek Saba; Richard Neil Harr...; Anur Guhan; Matthew E. Callister; Ramamurthy Sathya...; Sunita Rehal; John P. Corcoran; Robert Hallifax; Ioannis Psallidas; Nicky Russell; Rachel Shaw; Melissa Dobson; John M. Wrightson; Alex West; Y. C. Gary Lee; Andrew J. Nunn; Robert F. Miller; Nick A. Maskell; Najib M. Rahman
• Keywords: Pleurodesis; Pleural disease

Rationale: Patients with malignant pleural effusion experience breathlessness, which is treated by drainage and pleurodesis. Incomplete results in residual dyspnea pleurodesis failure. Intrapleural fibrinolytics lyse septations within fluid, improving drainage.Objectives: To assess the effects of intrapleural urokinase on success patients nondraining effusion.Methods: We conducted a prospective, double-blind, randomized trial. were randomly allocated 1:1 ratio to (100,000 IU, three doses, 12-hourly) or matched placebo.Measurements Main Results: Co–primary outcome measures (average daily 100-mm visual analog scale scores over 28 d) time failure 12 months. Secondary outcomes survival, hospital length stay, radiographic change. A total 71 subjects (36 received urokinase, 35 placebo) from U.K. centers. The baseline characteristics similar between groups. There was no difference mean groups (mean difference, 3.8 mm; 95% confidence interval [CI], −12 4.4 P = 0.36). Pleurodesis rates (urokinase, 13 [37%]; placebo, 11 34 [32%]; adjusted hazard ratio, 1.2; 0.65). Urokinase associated decreased size visualized chest radiography (adjusted relative improvement, −19%; CI, −28 −11%; < 0.001), reduced stay (1.6 d; 1.0 2.6; 0.049), improved survival (69 vs. 48 0.026).Conclusions: Use does not reduce improve compared placebo cannot be recommended as an adjunct Other palliative treatments should used. Improvements appearance, require further evaluation.Clinical trial registered ISRCTN (12852177) EudraCT (2008-000586-26).