Condition category
Surgery
Date applied
30/09/2005
Date assigned
30/09/2005
Last edited
21/04/2011
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 Christopher Little

ORCID ID

Contact details

Dept Orthopaedics
Northampton General Hospital NHS Trust
Northampton
NN1 5BD
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0162147151

Study information

Scientific title

Acronym

Study hypothesis

To establish whether tranexamic acid can reduce bleeding after knee replacement surgery without increasing the risk of deep venous thrombosis.

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

Not specified

Trial type

Not Specified

Patient information sheet

Condition

Surgery: Total knee arthroplasty

Intervention

Prospective, randomised controlled trial of 15 mg/ kg tranexamic acid v equivalent volume of normal saline given iv prior to tourniquet release during TKA

Intervention type

Drug

Phase

Not Specified

Drug names

tranexamic acid

Primary outcome measures

1. Blood loss in the first 48 hours post op
2. Transfusion requirements
3. Screen-detected DVT

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/11/2000

Overall trial end date

31/05/2004

Reason abandoned

Eligibility

Participant inclusion criteria

15 patients, 15 control patients of any age who are planned to have total knee arthroplasty

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

30

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

01/11/2000

Recruitment end date

31/05/2004

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Dept Orthopaedics
Northampton
NN1 5BD
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

Northampton General Hospital NHS Trust (UK), R&D NHS support funding

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

2006 results in http://www.ncbi.nlm.nih.gov/pubmed/16487712

Publication citations

  1. Results

    Orpen NM, Little C, Walker G, Crawfurd EJ, Tranexamic acid reduces early post-operative blood loss after total knee arthroplasty: a prospective randomised controlled trial of 29 patients., Knee, 2006, 13, 2, 106-110, doi: 10.1016/j.knee.2005.11.001.

Additional files

Editorial Notes