Condition category
Surgery
Date applied
30/09/2004
Date assigned
30/09/2004
Last edited
16/05/2012
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 M Loeffler

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0114126741

Study information

Scientific title

Acronym

Study hypothesis

Do autotransfusion drains obviate the need for formal blood transfusion with cross-matched blood after total knee arthroplasty?

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

Hospitals

Trial type

Other

Patient information sheet

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

Condition

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

Phase

Not Specified

Drug names

Primary outcome measures

Post operative Haemoglobin levels (checked at 12, 24 and 72 hours)

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/07/2003

Overall trial end date

31/12/2003

Reason abandoned

Eligibility

Participant inclusion criteria

100 patients will be selected for this study. All patients will need total knee replacements.

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

100

Participant exclusion criteria

Patients with bleeding disorders, Jehovah's witnesses and those not wishing to enter the study will be excluded.

Recruitment start date

01/07/2003

Recruitment end date

31/12/2003

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Colchester General Hospital
Colchester
CO4 5JL
United Kingdom

Sponsor information

Organisation

Department of Health

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Sponsor type

Government

Website

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

Funders

Funder type

Hospital/treatment centre

Funder name

Colchester Hospital University NHS Foundation Trust (UK)

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

1. 2008 results in http://www.ncbi.nlm.nih.gov/pubmed/18378918

Publication citations

  1. Results

    Amin A, Watson A, Mangwani J, Nawabi D, Ahluwalia R, Loeffler M, A prospective randomised controlled trial of autologous retransfusion in total knee replacement., J Bone Joint Surg Br, 2008, 90, 4, 451-454, doi: 10.1302/0301-620X.90B4.20044.

Additional files

Editorial Notes