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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02278263




Registration number
NCT02278263
Ethics application status
Date submitted
18/09/2014
Date registered
29/10/2014
Date last updated
12/12/2014

Titles & IDs
Public title
Tranexamic Acid in Knee Joint Surgery
Scientific title
Tranexamic Acid in Knee Joint Surgery - a Randomised Controlled Trial
Secondary ID [1] 0 0
TRACKS Study
Universal Trial Number (UTN)
Trial acronym
TRACKS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Osteoarthritis 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Osteoarthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Tranexamic Acid
Treatment: Drugs - Normal saline (0.9% NaCl)

Placebo Comparator: Control - Application of 20ml of normal saline (NaCl 0.9%) topically after implantation of prosthesis and left to sit for two minutes, excess carefully suctioned followed by standard closure with no drains; application of 15ml of normal saline intravenously at the same time prior to release of tourniquet.

Experimental: Topical - Application of 1.5g in 20ml tranexamic acid topically after implantation of prosthesis with excess carefully suctioned followed by standard closure with no drains; application of 15ml of normal saline intravenously at the same time prior to release of tourniquet.

Experimental: Systemic - Application of 20ml of normal saline topically after implantation of prosthesis with excess carefully suctioned followed by standard closure with no drains; Application of tranexamic acid intravenously (1.5g/15ml) at the same time prior to release of tourniquet


Treatment: Drugs: Tranexamic Acid
Given intravenously or topically

Treatment: Drugs: Normal saline (0.9% NaCl)
Administered in all 3 groups

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Blood loss - The loss of Hb (in grams) was then estimated according to the formula:
Hb(loss)=BV (blood volume) x (Hbi-Hbe) x 0.001+Hbt
where Hb (loss) (g) is the amount of Hb lost, Hbi (g/L) the Hb concentration before surgery, Hbe (g/L) is the Hbe concentration on the third day after surgery, and Hbt (g) is the total amount of allogeneic Hb transfused. A unit of banked blood is considered to contain a minimum of 40g Hb (Blood component data sheet, NZBS). All units of blood are processed and stored in a nationally standardised manner. The blood loss (ml) was related to the patient's preoperative Hb value (g/L):
Blood loss =1000 x Hb(loss) /Hbi
Timepoint [1] 0 0
Post operative day 3
Secondary outcome [1] 0 0
Pain - Using the Numeric rating scale (NRS)
Timepoint [1] 0 0
Postoperativley for the first 3 days after surgery, 4 times per day
Secondary outcome [2] 0 0
Function - Using the Oxford Knee Scores and range of movement (ROM)
Timepoint [2] 0 0
Preop, 6 weeks and 6 months
Secondary outcome [3] 0 0
Quality of Life - Using Short Form Health Survey 12 (SF-12)
Timepoint [3] 0 0
Preop, 6 weeks and 6 months
Secondary outcome [4] 0 0
Complications - Deep vein thrombosis/pulmonary embolus (DVT/PE), death, myocardial infarction/cerebrovascular accident (MI/CVA), infection (deep and superficial), manipulation under anaesthesia (MUA), urinary tract infection (UTI)
Timepoint [4] 0 0
Postoperatively withn 30 days after surgery
Secondary outcome [5] 0 0
Transfusion rates - Those patients receiving blood products. Standardised protocol is as follows:
The criterion for transfusion of blood products will be a haemoglobin < 80g/L or a haemoglobin <100g/L in a patient with ischaemic heart disease or with significant symptomatology
Timepoint [5] 0 0
Participants will be followed for the duration of their hospital stay expected to be an average of 3-5 days
Secondary outcome [6] 0 0
Length of stay (LOS) - Day of surgery is counted as Day 0.
Timepoint [6] 0 0
Average length of stay is expected to be 3 to 5 days
Secondary outcome [7] 0 0
Readmission rates - Returning to hospital for >24 hours admission
Timepoint [7] 0 0
All readmissions to hospital 30 days after date of surgery

Eligibility
Key inclusion criteria
- All patients at the participating sites on the waiting list for a unilateral total
knee joint replacement
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- Patients with a history or risk of thrombosis

- Active thromboembolic disease such as deep vein thrombosis, pulmonary embolism and
cerebral thrombosis

- Subarachnoid haemorrhage

- Hypersensitivity to tranexamic acid or any of its ingredients.

- Refusal of blood products

- Colour blindness

- Complex hematologic disorders requiring manipulation

- Coagulopathy

- Pregnant and Lactating Women

- Anti-coagulant therapy pre-operatively within 5 days of surgery (warfarin, dabigatran,
heparin)

- Severe renal failure (eGFR <29)

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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
Phase 4
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Unknown status
Data analysis
Reason for early stopping/withdrawal
Other reasons
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)
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Auckland
Country [2] 0 0
New Zealand
State/province [2] 0 0
Nelson
Country [3] 0 0
New Zealand
State/province [3] 0 0
Tauranga

Funding & Sponsors
Primary sponsor type
Other
Name
Andrew G Hill
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Total knee joint replacement surgery can lead to significant blood loss, which can affect
recovery after surgery. Tranexamic acid (TXA) is a medication which stops the breakdown of
blood clots and therefore prevents blood loss. The optimal use of TXA remains a point of
debate. Growing interest in the topical application of TXA (directly into the surgical wound)
has been suggested as an alternative way of administering TXA, and may demonstrate similar
effectiveness as when it is given intravenously. Therefore, this multicentred, randomized
controlled trial, aims to investigate the safety and effectiveness of both topical and
intravenous administrations of TXA in total knee joint surgery. The investigators predict
that both routes of administration will demonstrate similar results when compared to placebo.
Trial website
https://clinicaltrials.gov/show/NCT02278263
Trial related presentations / publications
Carson JL, Duff A, Berlin JA, Lawrence VA, Poses RM, Huber EC, O'Hara DA, Noveck H, Strom BL. Perioperative blood transfusion and postoperative mortality. JAMA. 1998 Jan 21;279(3):199-205.
Alshryda S, Sarda P, Sukeik M, Nargol A, Blenkinsopp J, Mason JM. Tranexamic acid in total knee replacement: a systematic review and meta-analysis. J Bone Joint Surg Br. 2011 Dec;93(12):1577-85. doi: 10.1302/0301-620X.93B12.26989. Review.
Sukeik M, Alshryda S, Haddad FS, Mason JM. Systematic review and meta-analysis of the use of tranexamic acid in total hip replacement. J Bone Joint Surg Br. 2011 Jan;93(1):39-46. doi: 10.1302/0301-620X.93B1.24984. Review.
Gandhi R, Evans HM, Mahomed SR, Mahomed NN. Tranexamic acid and the reduction of blood loss in total knee and hip arthroplasty: a meta-analysis. BMC Res Notes. 2013 May 7;6:184. doi: 10.1186/1756-0500-6-184.
CRASH-2 collaborators, Roberts I, Shakur H, Afolabi A, Brohi K, Coats T, Dewan Y, Gando S, Guyatt G, Hunt BJ, Morales C, Perel P, Prieto-Merino D, Woolley T. The importance of early treatment with tranexamic acid in bleeding trauma patients: an exploratory analysis of the CRASH-2 randomised controlled trial. Lancet. 2011 Mar 26;377(9771):1096-101, 1101.e1-2. doi: 10.1016/S0140-6736(11)60278-X.
Williams-Johnson JA, McDonald AH, Strachan GG, Williams EW. Effects of tranexamic acid on death, vascular occlusive events, and blood transfusion in trauma patients with significant haemorrhage (CRASH-2) A randomised, placebo-controlled trial. West Indian Med J. 2010 Dec;59(6):612-24.
Wind TC, Barfield WR, Moskal JT. The effect of tranexamic acid on blood loss and transfusion rate in primary total knee arthroplasty. J Arthroplasty. 2013 Aug;28(7):1080-3. doi: 10.1016/j.arth.2012.11.016. Epub 2013 Mar 28.
Wind TC, Barfield WR, Moskal JT. The effect of tranexamic acid on transfusion rate in primary total hip arthroplasty. J Arthroplasty. 2014 Feb;29(2):387-9. doi: 10.1016/j.arth.2013.05.026. Epub 2013 Jun 21.
Ishida K, Tsumura N, Kitagawa A, Hamamura S, Fukuda K, Dogaki Y, Kubo S, Matsumoto T, Matsushita T, Chin T, Iguchi T, Kurosaka M, Kuroda R. Intra-articular injection of tranexamic acid reduces not only blood loss but also knee joint swelling after total knee arthroplasty. Int Orthop. 2011 Nov;35(11):1639-45. doi: 10.1007/s00264-010-1205-3. Epub 2011 Jan 21.
Later AF, Sitniakowsky LS, van Hilten JA, van de Watering L, Brand A, Smit NP, Klautz RJ. Antifibrinolytics attenuate inflammatory gene expression after cardiac surgery. J Thorac Cardiovasc Surg. 2013 Jun;145(6):1611-6, 1616.e1-4. doi: 10.1016/j.jtcvs.2012.11.042. Epub 2013 Jan 16.
Robertshaw HJ. An anti-inflammatory role for tranexamic acid in cardiac surgery? Crit Care. 2008;12(1):105. doi: 10.1186/cc6210. Epub 2008 Jan 16.
Public notes

Contacts
Principal investigator
Name 0 0
Jacob T Munro, MBChB, FRACS
Address 0 0
Department of Surgery, The University of Auckland
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Marinus Stowers, MBChB
Address 0 0
Country 0 0
Phone 0 0
+64 9 2760044
Fax 0 0
Email 0 0
msto062@aucklanduni.ac.nz
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT02278263