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

Mishra, EK; Clive, AO; Wills, GH; Davies, HE; Stanton, AE; Al-Aloul, M; Hart-Thomas, A; ... Rahman, NM; + view all (2018) Randomised Controlled Trial of Urokinase versus Placebo for Non-draining Malignant Pleural Effusion. American Journal of Respiratory and Critical Care Medicine , 197 (4) pp. 502-508. 10.1164/rccm.201704-0809OC. Green open access

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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.

Type: Article
Title: Randomised Controlled Trial of Urokinase versus Placebo for Non-draining Malignant Pleural Effusion
Location: United States
Open access status: An open access version is available from UCL Discovery
DOI: 10.1164/rccm.201704-0809OC
Publisher version: http://dx.doi.org/10.1164/rccm.201704-0809OC
Language: English
Additional information: This version is the author accepted manuscript. For information on re-use, please refer to the publisher’s terms and conditions.
Keywords: effusion, fibrinolytic, malignant, pleural
UCL classification: UCL
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Life Sciences
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Life Sciences > UCL School of Pharmacy
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Life Sciences > UCL School of Pharmacy > Pharmacology
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Population Health Sciences > Inst of Clinical Trials and Methodology
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Population Health Sciences > Inst of Clinical Trials and Methodology > MRC Clinical Trials Unit at UCL
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Population Health Sciences > Institute for Global Health
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Population Health Sciences > Institute for Global Health > Infection and Population Health
URI: https://discovery.ucl.ac.uk/id/eprint/1575203
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