Condition category
Surgery
Date applied
18/12/2009
Date assigned
09/02/2010
Last edited
01/10/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Mr Shawn Tavares

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

Version 1, dated 24.08.09

Study information

Scientific title

Does intramedullary plugging reduce blood transfusion requirements in total knee replacement? A randomised controlled clinical trial

Acronym

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), 20/11/2009, ref: 09/H0505/117

Study design

Randomised controlled parallel-group trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

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

Phase

Not Applicable

Drug names

Primary outcome measures

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 trial start date

24/12/2009

Overall trial end date

30/01/2011

Reason abandoned

Eligibility

Participant inclusion criteria

Both male and female patients, aged 50-90 years, undergoing primary total knee replacement surgery

Participant type

Patient

Age group

Other

Gender

Both

Target number of participants

100

Participant exclusion criteria

Patients undergoing unicompartmental knee replacements and revision knee replacements

Recruitment start date

24/12/2009

Recruitment end date

30/01/2011

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Consultant Orthopaedic Surgeon
Reading
RG1 5AN
United Kingdom

Sponsor information

Organisation

Royal Berkshire NHS Foundation Trust (UK)

Sponsor details

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

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Hospital/treatment centre

Funder name

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

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes