Are autotransfusion drains effective for total knee arthroplasty? A randomised controlled trial

ISRCTN	ISRCTN65166542
DOI	https://doi.org/10.1186/ISRCTN65166542
Secondary identifying numbers	N0114126741

Submission date: 30/09/2004
Registration date: 30/09/2004
Last edited: 16/05/2012

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Surgery

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Mr M Loeffler
Scientific

Colchester General Hospital
Department of Orthopaedics
Turner Road
Colchester
CO4 5JL
United Kingdom

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Other
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title
Study objectives	Do autotransfusion drains obviate the need for formal blood transfusion with cross-matched blood after total knee arthroplasty?
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Surgery: Knee arthroplasty
Intervention	At the pre-admission clinic the patients will be randomly allocated into one of two groups (50 patients in each group) after discussing the project with them, providing them with a patients information leaflet and consenting them. One group will receive all their post operatively drained wound blood back as an autotransfusion using the "Bellovac" autotransfusion drain system. The other group will have their wound blood discarded and be transfused according to preset criteria. The autotransfused patients may need additional transfusion with cross-matched blood if they fail to meet the preset criteria. Transfusion criteria: 1. A loss of >1000 ml of blood in the collection drain; 2. A clinical need for transfusion (Tachycardia, hypotensive, ischaemic electrocardiogram [ECG] changes) 3. A haemoglobin blood level of <8.5 g/dl. The data will be collated to determine by simple non-parametric statistical analysis whether autotransfusion drains are useful in obviating the need for conventional transfusion with cross-matched donated blood. A publication in the Journal of Bone and Joint Surgery is anticipated.
Intervention type	Procedure/Surgery
Primary outcome measure	Post operative Haemoglobin levels (checked at 12, 24 and 72 hours)
Secondary outcome measures	Not provided at time of registration
Overall study start date	01/07/2003
Completion date	31/12/2003

Eligibility

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target number of participants	100
Key inclusion criteria	100 patients will be selected for this study. All patients will need total knee replacements.
Key exclusion criteria	Patients with bleeding disorders, Jehovah's witnesses and those not wishing to enter the study will be excluded.
Date of first enrolment	01/07/2003
Date of final enrolment	31/12/2003

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Colchester General Hospital

Colchester
CO4 5JL
United Kingdom

Sponsor information

Department of Health
Government

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Website	http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Hospital/treatment centre

Colchester Hospital University NHS Foundation Trust (UK)

No information available

Results and Publications

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

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/04/2008		Yes	No