Condition category
Musculoskeletal Diseases
Date applied
29/09/2006
Date assigned
29/09/2006
Last edited
22/09/2014
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 Sattar Alshryda

ORCID ID

Contact details

Dept of Orthopaedics
Fairfield General Hospital
Bury
BL9 7TD
United Kingdom
+44 (0) 77950 78485
Sattar26@hotmail.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0155164510

Study information

Scientific title

Acronym

Study hypothesis

Can we reduce blood loss associated with total hip replacement by using topical tranexamic acid?

Ethics approval

North West MREC Greater Manchester Strategic Health Authority, ref 05/MRE08/10, favourable ethical opinion on 11/04/2005, extended 02/02/2006

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

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

Condition

Musculoskeletal Diseases: total hip replacement

Intervention

Randomised controlled trial

Intervention type

Drug

Phase

Not Applicable

Drug names

Tranexamic acid

Primary outcome measures

Reduction in blood loss

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/06/2005

Overall trial end date

31/12/2006

Reason abandoned

Eligibility

Participant inclusion criteria

Patients having unilateral primary cemented total hip replacement

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

124

Participant exclusion criteria

1. Allergic to tranexamic acid
2. Pregnancy
3. History of DVT/pulmonary embolus
4. Patients involved in other trials
5. Known bleeding problems
6. Concurrent treatment with warfarin
7. Low dose molecular weight heparin or conventional heparin
8. Paget's disease or revision total hip replacement

Recruitment start date

01/06/2005

Recruitment end date

31/12/2006

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Dept of Orthopaedics
Bury
BL9 7TD
United Kingdom

Sponsor information

Organisation

Record Provided by the NHSTCT Register - 2006 Update - Department of Health

Sponsor details

The Department of Health
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

Pennine Acute Hospitals NHS Trust (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

NHS R&D Support Funding (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

2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/24196467

Publication citations

  1. Results

    Alshryda S, Mason J, Sarda P, Nargol A, Cooke N, Ahmad H, Tang S, Logishetty R, Vaghela M, McPartlin L, Hungin AP, Topical (intra-articular) tranexamic acid reduces blood loss and transfusion rates following total hip replacement: a randomized controlled trial (TRANX-H)., J Bone Joint Surg Am, 2013, 95, 21, 1969-1974, doi: 10.2106/JBJS.L.00908.

Additional files

Editorial Notes