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

ISRCTN	ISRCTN31343854
DOI	https://doi.org/10.1186/ISRCTN31343854
Secondary identifying numbers	N0176008571

Submission date: 30/09/2004
Registration date: 30/09/2004
Last edited: 05/03/2020

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

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

Contact information

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

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient 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	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)
Secondary outcome measures	Not provided at time of registration
Overall study start date	15/01/1998
Completion date	04/03/2004

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Upper age limit	85 Years
Sex	Both
Target number of participants	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

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Oxford Centre for Respiratory Medicine

Oxford
OX3 7LJ
United Kingdom

Sponsor information

Department of Health
Government

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Website	http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Hospital/treatment centre

Oxford Radcliffe Hospitals NHS Trust (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Editorial Notes

05/03/2020: No publications found. All search options exhausted.