Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000606482
Ethics application status
Approved
Date submitted
16/09/2014
Date registered
10/05/2016
Date last updated
21/04/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
Tranexamic acid use in Total Hip Replacement - beyond blood loss: a randomised clinical trial of efficacy of tranexamic acid in improving postoperative inpatient functional outcomes following anterior total hip replacement.
Scientific title
Comparing functional measures and blood loss with the of tranexamic acid in patients undergoing elective anterior total hip arthroplasty. A Randomized controlled trial.
Secondary ID [1] 285345 0
Nil
Universal Trial Number (UTN)
U1111-1161-7799
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hip Osteoarthrtitis 293069 0
Condition category
Condition code
Surgery 293344 293344 0 0
Other surgery
Musculoskeletal 293439 293439 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients will be randomly assigned to the control or experiment arm of the study by the pharmacist who will have a random sequence to dictate arm allocation. Those in the intervention arm will receive one 15mg per Kg intraoperative bolus of tranexamic acid intravenously at the time of induction of anaesthesia. With a further 15mg / kg bolus at 8hrs and 16 hours post procedure. The procedure duration is approximately 1 hour. This is the current protocol being employed by Orthopaedic surgeons and reflects the Australian Medical Handbook guidelines for dosing of tranexamic acid. The brand of tranexamic acid to be used will be Cyklokapron, currently the only product available in the Australian market.
Intervention code [1] 290260 0
Treatment: Drugs
Comparator / control treatment
Those in the control arm will receive an injection of an equal volume of normal saline at induction of anesthesia. Patients in the control arm will receive a further bolus of normal saline at 8 hours and 16 hours after the initial normal saline bolus.
Control group
Placebo

Outcomes
Primary outcome [1] 293178 0
Primary outcome: Thigh swelling. Thigh swelling is assessed using the frustum method of volumetric measurement.
Timepoint [1] 293178 0
Measured day 1, day 3 and 2 weeks post operatively.
Primary outcome [2] 293261 0
Functional measure - timed up and go test. Measured by recording the time taken to complete the test.
Timepoint [2] 293261 0
Measured day 1, day 3 and 2 weeks post operatively.
Secondary outcome [1] 310509 0
Secondary outcome: blood loss. This will be measured using observed blood loss intra-operatively as well as post operative haemoglobin levels.
Timepoint [1] 310509 0
Measured intra-operatively, day 1, day 3 post op.
Secondary outcome [2] 323564 0
Analgesia will be recorded using a visual analogue pain score.
Timepoint [2] 323564 0
Measured pre-operatively, day 1, day 3 and 2 weeks post op.

Eligibility
Key inclusion criteria
Eligible participants will be adults aged 40 or above undergoing a total hip replacement in the private practice of Mr Phong Tran.


Minimum age
40 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria are:
Contraindication to tranexamic acid use:
- Allergies or previously known drug reaction to tranexamic acid,
- Active intravascular clotting – DVT, PE or cerebral thrombosis
- Predisposition to thrombosis – previous documented DVT or PE
- Subarachnoid hemorrhage

Rheumatoid arthritis

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Patients will be recruited from the private rooms of Mr Phong Tran. Patients undergoing a primary total hip replacement will be invited to participate in the study. The parameters of the trial will be explained verbally and a consent form will be provided which will document the proposed aims, importance, risks and details of the intervention being studied. It will be re-enforced that the patient’s choice to participate in the trial will in no way affect their ability to receive the medical treatment which they are seeking. Allocation concealment will be carried out by the pharmacist preparing the medication. They will have a random number sequence which will be allocated to the patient's data sheet. They will allocate the patients to the arm of the trial. The randomisation sequence will not be available to the participating surgeon or anaesthetist. The patients will be correlated to the sequence at the time of completion of the trial for data analysis.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A random number sequence with an allocation of 1:1 will be generated using the STATA software package.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
1/02/2014
Date of last participant enrolment
Anticipated
31/12/2016
Actual
31/03/2016
Date of last data collection
Anticipated
Actual
30/04/2016
Sample size
Target
100
Accrual to date
Final
105
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 2984 0
St Vincents & Mercy Private Hospital - Mercy campus - East Melbourne
Recruitment postcode(s) [1] 8706 0
3002 - East Melbourne

Funding & Sponsors
Funding source category [1] 289957 0
Self funded/Unfunded
Name [1] 289957 0
Country [1] 289957 0
Primary sponsor type
Individual
Name
Dr Andrew Fraval
Address
St Vincent's Private Hospital
East Melbourne
159 Grey Street, East Melbourne VIC 3002
Country
Australia
Secondary sponsor category [1] 288648 0
None
Name [1] 288648 0
Address [1] 288648 0
Country [1] 288648 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291674 0
St Vincent’s HREC-D
Ethics committee address [1] 291674 0
Ethics committee country [1] 291674 0
Australia
Date submitted for ethics approval [1] 291674 0
23/08/2013
Approval date [1] 291674 0
11/09/2013
Ethics approval number [1] 291674 0
HRECD - 107/13

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 51466 0
Dr Andrew Fraval
Address 51466 0
St Vincent's Private Hospital
East Melbourne
159 Grey Street, East Melbourne VIC 3002
Country 51466 0
Australia
Phone 51466 0
+ 61 423 155 386
Fax 51466 0
Email 51466 0
[email protected]
Contact person for public queries
Name 51467 0
Andrew Fraval
Address 51467 0
St Vincent's Private Hospital
East Melbourne
159 Grey Street, East Melbourne VIC 3002
Country 51467 0
Australia
Phone 51467 0
+ 61 423 155 386
Fax 51467 0
Email 51467 0
[email protected]
Contact person for scientific queries
Name 51468 0
Andrew Fraval
Address 51468 0
St Vincent's Private Hospital
East Melbourne
159 Grey Street, East Melbourne VIC 3002
Country 51468 0
Australia
Phone 51468 0
+ 61 423 155 386
Fax 51468 0
Email 51468 0
[email protected]

No information has been provided regarding IPD availability


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
EmbaseOBTAIN E: outcome benefits of tranexamic acid in hip arthroplasty with enoxaparin: a randomised double-blinded controlled trial.2019https://dx.doi.org/10.1177/1120700018780125
N.B. These documents automatically identified may not have been verified by the study sponsor.