ISRCTN ISRCTN78657174
DOI https://doi.org/10.1186/ISRCTN78657174
Protocol serial number N0650147585
Sponsor Department of Health
Funder Southport and Ormskirk Hospital NHS Trust (UK)
Submission date
30/09/2005
Registration date
30/09/2005
Last edited
08/04/2014
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Surgery
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

Contact information

Mr T Menon
Scientific

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

Study information

Primary study designInterventional
Study designRandomised controlled trial
Secondary study designRandomised controlled trial
Scientific title
Study objectivesDoes 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(s)Not provided at time of registration
Health condition(s) or problem(s) studiedSurgery: Total joint arthroplasty
InterventionPatients 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 typeProcedure/Surgery
Primary outcome measure(s)

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

Key secondary outcome measure(s)

Not provided at time of registration

Completion date31/03/2005

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexNot Specified
Target sample size at registration120
Key inclusion criteria60 hip replacements and 60 knee replacements
Key exclusion criteriaNot provided at time of registration
Date of first enrolment01/09/2002
Date of final enrolment31/03/2005

Locations

Countries of recruitment

  • United Kingdom
  • England

Study participating centre

Ormskirk & District General Hospital
Ormskirk
L39 2AZ
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
IPD sharing plan