Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0650147585
Study information
Scientific title
Acronym
Study hypothesis
Does the routine use of drains alter the post operative blood loss and hence influence the need for blood transfusions in hip and knee arthroplasties?
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: Total joint arthroplasty
Intervention
Patients undergoing hip and knee arthroplasties will be randomized into two groups, one with and the other without post-op closed suction drains. Parameters studied will include post-operative blood loss, blood transfusion requirements, duration of hospital stay, complications if any, and the immediate and short term functional outcome. All patients will be consented after providing details of the study. Copy of consent and proforma for study in hard copy file.
Intervention type
Procedure/Surgery
Phase
Not Specified
Drug names
Primary outcome measure
Volume of blood loss, volume of blood transfused and functional outcome.
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/09/2002
Overall trial end date
31/03/2005
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
60 hip replacements and 60 knee replacements
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
120
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
01/09/2002
Recruitment end date
31/03/2005
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Ormskirk & District General Hospital
Ormskirk
L39 2AZ
United Kingdom
Sponsor information
Organisation
Department of Health
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Southport and Ormskirk Hospital 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