Does intramedullary plugging reduce blood transfusion requirements in total knee replacement?

ISRCTN	ISRCTN94713892
DOI	https://doi.org/10.1186/ISRCTN94713892
Secondary identifying numbers	Version 1, dated 24.08.09

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Mr Shawn Tavares
Scientific

Consultant Orthopaedic Surgeon
Trauma and Orthopaedic Department
Royal Berkshire NHS Foundation Trust
London Road
Reading
RG1 5AN
United Kingdom

Study design	Randomised controlled parallel-group trial
Primary study design	Interventional
Secondary study design	Randomised parallel trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details to request a patient information sheet
Scientific title	Does intramedullary plugging reduce blood transfusion requirements in total knee replacement? A randomised controlled clinical trial
Study objectives	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(s)	Berkshire Research Ethics Committee (REC), 20/11/2009, ref: 09/H0505/117
Health condition(s) or problem(s) studied	Trauma and Orthopaedics - total knee replacements
Intervention	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.
Intervention type	Procedure/Surgery
Primary outcome measure	Allogenic blood transfusion requirements
Secondary outcome measures	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
Overall study start date	24/12/2009
Completion date	30/01/2011

Participant type(s)	Patient
Age group	Other
Sex	Both
Target number of participants	100
Key inclusion criteria	1. Male and female patients 2. Aged 50-90 years 3. Undergoing primary total knee replacement surgery
Key exclusion criteria	Patients undergoing unicompartmental knee replacements and revision knee replacements
Date of first enrolment	24/12/2009
Date of final enrolment	30/01/2011

Royal Berkshire NHS Foundation Trust

Reading
RG1 5AN
United Kingdom

Royal Berkshire NHS Foundation Trust (UK)
Hospital/treatment centre

c/o Leslie Frederick
Research and Development Office
Royal Berkshire NHS Foundation Trust
London Road
Reading
Reading
RG1 5AN
England
United Kingdom

"ROR"	https://ror.org/034nvrd87

Hospital/treatment centre

Royal Berkshire NHS Foundation Trust (UK) - Trauma and Orthopaedic Department

No information available

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

22/05/2017: No publications found, verifying study status with principal investigator.