Trial Review

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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12610001065088
Ethics application status
Approved
Date submitted
20/08/2010
Date registered
3/12/2010
Date last updated
19/11/2019
Date data sharing statement initially provided
19/11/2019
Date results information initially provided
19/11/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Does Tranexamic Acid reduce transfusion rate in Total Hip Replacements?
Scientific title
In patients undergoing primary total hip replacements for osteoarthritis or avascular necrosis (AVN), does the use of tranexamic acid just prior to surgery reduce the transfusion rate and units transfused when compared to a placebo?
Secondary ID [1] 252220 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Osteoarthritis 257742 0
Avascular necrosis of the femoral head 258677 0
Condition category
Condition code
Musculoskeletal 257916 257916 0 0
Osteoarthritis
Musculoskeletal 258823 258823 0 0
Other muscular and skeletal disorders
Surgery 258824 258824 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
1g Intravenous Tranexamic acid infused ove 10 minutes just prior to surgery.
Intervention code [1] 256805 0
Treatment: Drugs
Intervention code [2] 257637 0
Prevention
Comparator / control treatment
Normal saline 10mls infused over 10minutes just prior to surgery
Control group
Placebo

Outcomes
Primary outcome [1] 259041 0
Reduction in total units transfused over selected number of patients. From current average of 0.3units per patient to 0.15 units per patient. Data to be recorded from patient notes
Timepoint [1] 259041 0
One Week post surgery
Secondary outcome [1] 265292 0
Reduction in blood loss post-operatively. Using amount of blood drained from subfascial drain left in place for 24 hours. Data to be taken from patient notes
Timepoint [1] 265292 0
First 24 hours post surgery
Secondary outcome [2] 265293 0
Reduction in post-operative Haemoglobin drop. Haemoglobin to be check pre-op and Day 1 post-operatively and Day 5 post-operatively. Looking for differenced in expected post-operative drop
Timepoint [2] 265293 0
Five Days post surgery

Eligibility
Key inclusion criteria
Primary total hip replacement
Diagnosis of osteoarthritis or avascular necrosis
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Contraindications for tranexamic acid
Bleeding disorder
Use of Warfarin or Clexane or clopidogrel
History of thromboembolic disorder

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Block randomisation using sealed envelopes. To be opened by those providing the medication sterile.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?

The people administering the treatment/s

Intervention assignment
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
6/12/2010
Actual
15/08/2011
Date of last participant enrolment
Anticipated
Actual
31/12/2016
Date of last data collection
Anticipated
Actual
1/06/2017
Sample size
Target
200
Accrual to date
Final
88
Recruitment outside Australia
Country [1] 2763 0
New Zealand
State/province [1] 2763 0
Hawkes Bay
Country [2] 22125 0
New Zealand
State/province [2] 22125 0
Canterbury

Funding & Sponsors
Funding source category [1] 257503 0
Self funded/Unfunded
Name [1] 257503 0
Country [1] 257503 0
Primary sponsor type
Individual
Name
Dr James Blackett
Address
Hawkes Bay Hospital
Omahu Road
Hastings 4120
NEW ZEALAND
Country
New Zealand
Secondary sponsor category [1] 256736 0
Individual
Name [1] 256736 0
Mr Simon Johnson
Address [1] 256736 0
Hawkes Bay Hospital
Omahu Road
Hastings 4120
NEW ZEALAND
Country [1] 256736 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259531 0
Ethics committee address [1] 259531 0
Ethics committee country [1] 259531 0
Date submitted for ethics approval [1] 259531 0
01/09/2010
Approval date [1] 259531 0
11/07/2011
Ethics approval number [1] 259531 0

Summary
Brief summary
The aim of the study is to reduce the blood transfusion rate after a total hip replacement by giving a medication (tranexamic acid) through the vein just before the operation starts. This medication has been shown to be safe in most patients in similar studies overseas and is occasionly used in situations of extreme blood loss in New Zealand currently. It has been shown to reduce blood loss in routine total hip replacements in previous research performed overseas however it's effect on transfusion has not been assesed as a primary outcome. It is not routinely used in New Zealand currently
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31394 0
Dr James Blackett
Address 31394 0
Hawkes Bay Hospital
Omahu Road
Hastings
Country 31394 0
New Zealand
Phone 31394 0
+64 21 878 8109
Fax 31394 0
Email 31394 0
james.blackett@hawkesbaydhb.govt.nz
Contact person for public queries
Name 14641 0
Dr Dr James Blackett
Address 14641 0
Hawkes Bay Hospital
Omahu Road
Hastings 4120
Country 14641 0
New Zealand
Phone 14641 0
+64 6 878 8109
Fax 14641 0
Email 14641 0
james.blackett@hawkesbaydhb.govt.nz
Contact person for scientific queries
Name 5569 0
Dr Dr James Blackett
Address 5569 0
Hawkes Bay Hospital
Omahu Road
Hastings 4120
Country 5569 0
New Zealand
Phone 5569 0
+64 6 878 8109
Fax 5569 0
Email 5569 0
james.blackett@hawkesbaydhb.govt.nz

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseThe Value of Routine Intravenous Tranexamic Acid in Total Hip Arthroplasty: A Preliminary Study.2020https://dx.doi.org/10.1155/2020/2943827
N.B. These documents automatically identified may not have been verified by the study sponsor.