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

ISRCTN	ISRCTN94713892
DOI	https://doi.org/10.1186/ISRCTN94713892
Protocol serial number	Version 1, dated 24.08.09
Sponsor	Royal Berkshire NHS Foundation Trust (UK)
Funder	Royal Berkshire NHS Foundation Trust (UK) - Trauma and Orthopaedic Department

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

Primary study design	Interventional
Study design	Randomised controlled parallel-group trial
Secondary study design	Randomised parallel trial
Study type	Participant 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(s)	Allogenic blood transfusion requirements
Key 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
Completion date	30/01/2011

Participant type(s)	Patient
Age group	Other
Sex	All
Target sample size at registration	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

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

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