Condition category
Surgery
Date applied
30/09/2005
Date assigned
30/09/2005
Last edited
08/04/2014
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 T Menon

ORCID ID

Contact details

Ormskirk & District General Hospital
Wigan Road
Ormskirk
L39 2AZ
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0650147585

Study information

Scientific title

Acronym

Study hypothesis

Does the routine use of drains alter the post operative blood loss and hence influence the need for blood transfusions in hip and knee arthroplasties?

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

Treatment

Patient information sheet

Condition

Surgery: Total joint arthroplasty

Intervention

Patients undergoing hip and knee arthroplasties will be randomized into two groups, one with and the other without post-op closed suction drains. Parameters studied will include post-operative blood loss, blood transfusion requirements, duration of hospital stay, complications if any, and the immediate and short term functional outcome. All patients will be consented after providing details of the study. Copy of consent and proforma for study in hard copy file.

Intervention type

Procedure/Surgery

Phase

Not Specified

Drug names

Primary outcome measures

Volume of blood loss, volume of blood transfused and functional outcome.

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/09/2002

Overall trial end date

31/03/2005

Reason abandoned

Eligibility

Participant inclusion criteria

60 hip replacements and 60 knee replacements

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

120

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

01/09/2002

Recruitment end date

31/03/2005

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Ormskirk & District General Hospital
Ormskirk
L39 2AZ
United Kingdom

Sponsor information

Organisation

Department of Health

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk

Sponsor type

Government

Website

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

Funders

Funder type

Government

Funder name

Southport and Ormskirk Hospital NHS 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

Publication citations

Additional files

Editorial Notes