Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0162147151
Study information
Scientific title
Acronym
Study hypothesis
To establish whether tranexamic acid can reduce bleeding after knee replacement surgery without increasing the risk of deep venous thrombosis.
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
Not specified
Trial type
Not Specified
Patient information sheet
Condition
Surgery: Total knee arthroplasty
Intervention
Prospective, randomised controlled trial of 15 mg/ kg tranexamic acid v equivalent volume of normal saline given iv prior to tourniquet release during TKA
Intervention type
Drug
Phase
Not Specified
Drug names
tranexamic acid
Primary outcome measure
1. Blood loss in the first 48 hours post op
2. Transfusion requirements
3. Screen-detected DVT
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/11/2000
Overall trial end date
31/05/2004
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
15 patients, 15 control patients of any age who are planned to have total knee arthroplasty
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
30
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
01/11/2000
Recruitment end date
31/05/2004
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Dept Orthopaedics
Northampton
NN1 5BD
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
Northampton General Hospital NHS Trust (UK), R&D NHS support funding
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
2006 results in http://www.ncbi.nlm.nih.gov/pubmed/16487712
Publication citations
-
Results
Orpen NM, Little C, Walker G, Crawfurd EJ, Tranexamic acid reduces early post-operative blood loss after total knee arthroplasty: a prospective randomised controlled trial of 29 patients., Knee, 2006, 13, 2, 106-110, doi: 10.1016/j.knee.2005.11.001.