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Randomised Controlled Trial of Urokinase versus Placebo for Non-draining Malignant Pleural Effusion.

Randomised Controlled Trial of Urokinase versus Placebo for Non-draining Malignant Pleural Effusion.
Author Information (click to view)

Mishra EK, Clive AO, Wills GH, Davies HE, Stanton AE, Al-Aloul M, Hart-Thomas A, Pepperell J, Evison M, Saba T, Harrison RN, Guhan A, Callister ME, Sathyamurthy R, Rehal S, Corcoran JP, Hallifax R, Psallidas I, Russell N, Shaw R, Dobson M, Wrightson JM, West A, Lee YCG, Nunn AJ, Miller RF, Maskell NA, Rahman NM,


Mishra EK, Clive AO, Wills GH, Davies HE, Stanton AE, Al-Aloul M, Hart-Thomas A, Pepperell J, Evison M, Saba T, Harrison RN, Guhan A, Callister ME, Sathyamurthy R, Rehal S, Corcoran JP, Hallifax R, Psallidas I, Russell N, Shaw R, Dobson M, Wrightson JM, West A, Lee YCG, Nunn AJ, Miller RF, Maskell NA, Rahman NM, (click to view)

Mishra EK, Clive AO, Wills GH, Davies HE, Stanton AE, Al-Aloul M, Hart-Thomas A, Pepperell J, Evison M, Saba T, Harrison RN, Guhan A, Callister ME, Sathyamurthy R, Rehal S, Corcoran JP, Hallifax R, Psallidas I, Russell N, Shaw R, Dobson M, Wrightson JM, West A, Lee YCG, Nunn AJ, Miller RF, Maskell NA, Rahman NM,

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American journal of respiratory and critical care medicine 2017 09 19() doi 10.1164/rccm.201704-0809OC

Abstract
RATIONALE
Patients with malignant pleural effusion (MPE) experience breathlessness, which is treated by drainage and pleurodesis. Incomplete drainage results in residual dyspnea and pleurodesis failure. Intrapleural fibrinolytics lyse septations within pleural fluid, improving drainage.

OBJECTIVES
To assess the effects of intrapleural urokinase on dyspnea and pleurodesis success in patients with non-draining malignant effusion.

METHODS
Prospective double blind randomised trial; patients with non-draining effusion were randomly allocated 1:1 to intrapleural urokinase (100,000 IU three doses 12 hourly) or matched placebo.

MEASUREMENTS
Co-primary outcome measures: dyspnea (average daily 100mm visual analogue scores over 28 days) and time to pleurodesis failure to 12 months.

SECONDARY OUTCOMES
survival, time in hospital and radiographic change.

MAIN RESULTS
71 subjects randomised (36 received urokinase, 35 placebo) from 12 UK Centres. Baseline characteristics were similar between groups. There was no difference in mean dyspnea between groups (mean difference 3·8mm, 95% CI -12 to 4·4mm, p=0·36). Pleurodesis failure rates were similar (urokinase 13/35 (37%), placebo 11/34 (32%), adjusted hazard ratio 1·2, p=0·65). Urokinase was associated with a decreased effusion size on chest radiograph (adjusted relative improvement -19% (95% CI -28 to -11%, p<0·001), reduced hospital stay (1·6 days (95% CI 1·0 to 2·6), p=0·049) and improved survival (69 days versus 48 days, p=0.026). CONCLUSIONS
Use of intrapleural urokinase does not reduce dyspnea or improve pleurodesis success compared with placebo, and cannot be recommended as an adjunct to pleurodesis. Other palliative treatments should be used. Improvements in hospital stay, radiographic appearance and survival associated with urokinase require further evaluation. Clinical trial registration available at www.isrctn.com, ID 12852177.

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