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Trial registered on ANZCTR


Trial ID
ACTRN12613001043729
Ethics application status
Submitted, not yet approved
Date submitted
16/09/2013
Date registered
19/09/2013
Date last updated
15/10/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
Novel use of tranexamic acid in major joint surgery
Scientific title
Prospective randomised equivalence trial to compare blood loss and transfusion rates for periarticular and intravenous administration of tranexamic acid in primary hip and knee joint arthroplasty.
Secondary ID [1] 283223 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anaemia
290096 0
Major Joint Surgery
290106 0
Condition category
Condition code
Blood 290470 290470 0 0
Anaemia
Surgery 290485 290485 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
1 gram of tranexamic acid directly infiltrated into the periarticular tissues mixed with the standard local anaesthetic solution. The local infiltration analgesic (LIA) mixture consists of 150mls of 0.2% ropivicaine with 5micrograms per ml of adrenaline.
Intervention code [1] 287953 0
Treatment: Drugs
Comparator / control treatment
1 gram of tranexamic acid given intravenously during surgery followed by another 1 gram six hours post-operatively.
Control group
Active

Outcomes
Primary outcome [1] 290495 0
Blood loss as calculated by the haemoglobin balance method.

This method assumes that the blood volume (BV in ml) on the 5fth day after surgery is the same as that before surgery. BV is estimated by taking sex, body mass and height into account. The loss of Hb (in grams) was then estimated according to the formula:

Hb loss=BV x (Hbi-Hbe) x 0.001+Hbt

where Hb loss (g) is the amount of Hb lost, Hbi (g/litre) the
Hb concentration before surgery, Hbe (g/litre) is the Hb
concentration on the 5fth day after surgery and Hbt (g) is the
total amount of allogeneic Hb transfused. A unit of banked
blood was considered to contain 63g Hb at our institution. The blood loss (ml) was related to the patient's preoperative Hb value (g/litre):

Blood loss =1000 x Hbloss/Hbi
Timepoint [1] 290495 0
Preoperative Hb and Postoperative Day 1,3, & 5.
Secondary outcome [1] 304633 0
Red Cell Transfusion rates. The number of units of red cell transfusion administered during the post-operative in-patient stay will be recorded.
Timepoint [1] 304633 0
red cell transfusion rates will be recorded at any time during the inaptient stay up to 1 week post-operatively.

Eligibility
Key inclusion criteria
Primary unilateral total hip arthroplasty
Primary unilateral total knee arthroplasty
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Revision Hip or Knee Arthroplasty
Unicompartment (Oxford) knee arthroplasty
Cardiac Stents
Prior stroke or myocardial infarction
History of deep venous thrombosis or pulmonary embolus
Any thrombophilia
Oral contraceptive pill
Pregnancy or breast feeding
End stage renal failure
Peripheral vascular disease with vascular stents

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)
All patients referred for joint replacement surgery to the nominated surgeons consecutively.
Allocation concealment by concealed envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A web based randomization schedule will be used to randomize
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Equivalence trial
Phase
Type of endpoint(s)
Efficacy
Statistical methods / analysis
An equivalence test of means using two one-sided tests on data from a parallel-group design with sample sizes of 45 in the reference group and 45 in the treatment group achieves 81% power at a 5% significance level when the true difference between the means is 0, the standard deviation is 480mls, and the equivalence limits are -300mls and 300mls.

Recruitment
Recruitment status
Withdrawn
Reason for early stopping/withdrawal
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 1524 0
Hollywood Private Hospital - Nedlands
Recruitment postcode(s) [1] 7362 0
6009 - Nedlands

Funding & Sponsors
Funding source category [1] 287972 0
Self funded/Unfunded
Name [1] 287972 0
Address [1] 287972 0
Country [1] 287972 0
Primary sponsor type
Individual
Name
Dr Mark J Lennon
Address
Hollywood Private Hospital
Monash Avenue
Nedlands
WA 6009
Country
Australia
Secondary sponsor category [1] 286692 0
Individual
Name [1] 286692 0
Professor Riaz Khan
Address [1] 286692 0
The Joint Studio
Suite 1 Hollywood Medical Centre
85 Monash Avenue, Nedlands 6009

Country [1] 286692 0
Australia

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 289897 0
Hollywood Hospital Research Ethics Committee
Ethics committee address [1] 289897 0
Hollywood Private Hospital
Locked Bag 2002
NEDLANDS, WA 6909
Ethics committee country [1] 289897 0
Australia
Date submitted for ethics approval [1] 289897 0
16/09/2013
Approval date [1] 289897 0
Ethics approval number [1] 289897 0

Summary
Brief summary
Major joint surgery is associated with significant blood loss which often requires transfusion. Tranexamic acid is a recommended medication to assist with limiting blood loss. It acts by preventing the breakdown of blood clot. The usual dosage is multiple intravenous injections. The optimal dose is unknown. This study will examine the effects of direct injection of tranexamic acid into the site of surgery and compare this to the intravenous route. The hypothesis is that this will be as effective if not more effective than intravenous use and is easier to administer.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 42978 0
Dr Mark J Lennon
Address 42978 0
Hollywood Private Hospital
Monash Avenue
Nedlands
WA 6009
Country 42978 0
Australia
Phone 42978 0
+61 8 93466000
Fax 42978 0
Email 42978 0
mjlennon3@bigpond.com
Contact person for public queries
Name 42979 0
Dr Mark J Lennon
Address 42979 0
Hollywood Private Hospital
Monash Avenue
Nedlands
WA 6009
Country 42979 0
Australia
Phone 42979 0
+61 8 93466000
Fax 42979 0
Email 42979 0
mjlennon3@bigpond.com
Contact person for scientific queries
Name 42980 0
Dr Mark J Lennon
Address 42980 0
Hollywood Private Hospital
Monash Avenue
Nedlands
WA 6009
Country 42980 0
Australia
Phone 42980 0
+61 8 93466000
Fax 42980 0
Email 42980 0
mjlennon3@bigpond.com