Randomised controlled trial of fibrinolytic aided pleural drainage during chemical pleurodesis for malignant pleural effusion

ISRCTN	ISRCTN31343854
DOI	https://doi.org/10.1186/ISRCTN31343854
Protocol serial number	N0176008571
Sponsor	Department of Health
Funder	Oxford Radcliffe Hospitals NHS Trust (UK)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Dr Robert J O Davies
Scientific

Oxford Centre for Respiratory Medicine
Churchill Hospital
Churchill Drive
Headington
Oxford
OX3 7LJ
United Kingdom

Phone	+44 (0)1865 225256
Email	abc@email.com

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Randomised controlled trial of fibrinolytic aided pleural drainage during chemical pleurodesis for malignant pleural effusion
Study objectives	Some patients with cancer become breathless because fluid, repeatedly collects in the space between the lung and the chest wall (the pleural cavity). To control this problem fluid is drained from the cavity and then the walls of the cavity can be 'stuck together' with an irritant solution. This often fails when the fluid in the chest is clollected into separate locules and so the fluid does not drain effectively. This study assesses whether improving the draining of such loculated fluid with streptokinase improves the efficacy of the subsequent irritant solution 'sticking process'.
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Malignant pleural effusion
Intervention	A randomised controlled trial
Intervention type	Other
Primary outcome measure(s)	1. Time to first post pleurodesis aspiration 2. Time to first increase in pleural shadow on chest radiograph 3. Number of patients requiring a further pleural drainage before death or two years follow-up (FU)
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	04/03/2004

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Upper age limit	85 Years
Sex	All
Target sample size at registration	40
Key inclusion criteria	40 patients: 1. Confirmed pleural malignancy 2. Recurrent symptomatic pleural effusion 3. Aged 18-85 40 control patients, same criteria.
Key exclusion criteria	Previous pleurodesis
Date of first enrolment	15/01/1998
Date of final enrolment	04/03/2004

Oxford Centre for Respiratory Medicine

Oxford
OX3 7LJ
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

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