Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0176008571
Study information
Scientific title
Acronym
Study hypothesis
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
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Malignant pleural effusion
Intervention
A randomised controlled trial
Intervention type
Other
Phase
Not Specified
Drug names
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 trial start date
15/01/1998
Overall trial end date
04/03/2004
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
40 patients:
1. Confirmed pleural malignancy
2. Recurrent symptomatic pleural effusion
3. Aged 18-85
40 control patients, same criteria.
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
40
Participant exclusion criteria
Previous pleurodesis
Recruitment start date
15/01/1998
Recruitment end date
04/03/2004
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Oxford Centre for Respiratory Medicine
Oxford
OX3 7LJ
United Kingdom
Sponsor information
Organisation
Department of Health
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Hospital/treatment centre
Funder name
Oxford Radcliffe Hospitals NHS Trust (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list