Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0234117607
Study information
Scientific title
Fibrin sealant to reduce blood loss after hip replacement
Acronym
Study hypothesis
Does fibrin sealant reduce blood loss after primary and revision hip replacement?
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
Condition
Surgery: Hip replacement
Intervention
Two groups: Revision total hip replacement and Primary total hip replacement.
Intervention type
Procedure/Surgery
Phase
Not Specified
Drug names
Primary outcome measure
Quantitative estimate of per-operative blood loss, measurement of post-operative blood loss volume via drains, post-operative haemaglobin level, number of patients requiring blood transfusion.
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/08/2002
Overall trial end date
31/07/2003
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Primary hip replacement: 60 patients not on anticoagulant medications, without blood autoantibodies and with pre-operation Hb level >12.5 will be randomised into treatment and control groups.
Revision hip replacement: 30 consecutive patients in treatment group not randomized. Control group will be historical, with information regarding blood loss gained from a retrospective review of notes.
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
90
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
01/08/2002
Recruitment end date
31/07/2003
Locations
Countries of recruitment
United Kingdom
Trial participating centre
North Bristol NHS Trust
Bristol
BS10 5NB
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
Government
Funder name
North Bristol 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