Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0176120413
Study information
Scientific title
Acronym
Study hypothesis
Is using a sealing device superior to femoral compression for haemostasis following angiography or angioplasty?
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
Haemostasis
Intervention
Randomised contolled trial. Sealed envelopes will be used with the different randomisations.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measure
The time to obtain haemostasis and development of any haemotoma during a 1 week period.
Secondary outcome measures
Not provided at time of registration
Overall trial start date
26/02/2003
Overall trial end date
26/02/2004
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
300 patients
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
300
Participant exclusion criteria
Does not match inclusion criteria
Recruitment start date
26/02/2003
Recruitment end date
26/02/2004
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Radiology Department
Oxford
OX3 9DU
United Kingdom
Sponsor information
Organisation
Department of Health (UK)
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
1. 2007 results in http://www.ncbi.nlm.nih.gov/pubmed/17071040
Publication citations
-
Results
Upponi SS, Ganeshan AG, Warakaulle DR, Phillips-Hughes J, Boardman P, Uberoi R, Angioseal versus manual compression for haemostasis following peripheral vascular diagnostic and interventional procedures--a randomized controlled trial., Eur J Radiol, 2007, 61, 2, 332-334, doi: 10.1016/j.ejrad.2006.09.007.