|
ISRCTN
|
ISRCTN94713892
|
|
ClinicalTrials.gov identifier
|
N/A
|
|
Public title
|
Does intramedullary plugging reduce blood transfusion requirements in total knee replacement?
|
|
Scientific title
|
Does intramedullary plugging reduce blood transfusion requirements in total knee replacement?: A randomised controlled clinical trial
|
|
Acronym
|
N/A
|
|
Serial number at source
|
Version 1, dated 24.08.09
|
|
Study hypothesis
|
To assess if intramedullary plugging, when used together with an autologous retransfusion drain, reduces blood loss to make significant differences in allogenic blood requirements in patients undergoing total knee replacement
|
|
Ethics approval
|
Berkshire Research Ethics Committee (REC) approved on the 20th November 2009 (ref: 09/H0505/117)
|
|
Study design
|
Randomised controlled parallel group trial
|
|
Countries of recruitment
|
United Kingdom
|
|
Disease/condition/study domain
|
Trauma and Orthopaedics - total knee replacements
|
|
Participants - inclusion criteria
|
Both male and female patients, aged 50-90 years, undergoing primary total knee replacement surgery
|
|
Participants - exclusion criteria
|
Patients undergoing unicompartmental knee replacements and revision knee replacements
|
|
Anticipated start date
|
24/12/2009
|
|
Anticipated end date
|
30/01/2011
|
|
Status of trial
|
Ongoing |
|
Patient information material
|
Not available in web format, please use the contact details below to request a patient information sheet
|
|
Target number of participants
|
100
|
|
Interventions
|
Patients who have total knee arthroplasty will be randomised into two groups. One group will have intramedullary plugging with retransfusion drains and one group will have retransfusion drains only.
|
|
Primary outcome measure(s)
|
Allogenic blood transfusion requirements
|
|
Secondary outcome measure(s)
|
Post-operative blood loss assessed by:
1. Haemoglobin levels in first 3-days of the post-operative period
2. Total amount of blood collected in drain in the first 24 hours after surgery
|
|
Sources of funding
|
Royal Berkshire NHS Foundation Trust (UK) - Trauma and Orthopaedic Department
|
|
Trial website
|
|
|
Publications
|
|
|
Contact name
|
Mr
Shawn
Tavares
|
|
Address
|
Consultant Orthopaedic Surgeon
Trauma and Orthopaedic Department
Royal Berkshire NHS Foundation Trust
London Road
|
|
City/town
|
Reading
|
|
Zip/Postcode
|
RG1 5AN
|
|
Country
|
United Kingdom
|
|
Sponsor
|
Royal Berkshire NHS Foundation Trust (UK)
|
|
Address
|
c/o Leslie Frederick
Research and Development Office
Royal Berkshire NHS Foundation Trust
London Road
Reading
|
|
City/town
|
Reading
|
|
Zip/Postcode
|
RG1 5AN
|
|
Country
|
United Kingdom
|
|
Date applied
|
18/12/2009
|
|
Last edited
|
09/02/2010
|
|
Date ISRCTN assigned
|
09/02/2010
|
