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Trial details imported from ClinicalTrials.gov

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




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

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
Timepoint [1] 0 0
Post operative day 3
Secondary outcome [1] 0 0
Number of Participants Experiencing Symptomatic Venothromboembolic (VTE) Disease
Timepoint [1] 0 0
Postoperatively within 30 days after surgery
Secondary outcome [2] 0 0
Number of Participants Receiving Allogenic Blood Transfusion
Timepoint [2] 0 0
Participants will be followed for the duration of their hospital stay expected to be an average of 3-5 days
Secondary outcome [3] 0 0
Length of Stay (LOS)
Timepoint [3] 0 0
Average length of stay is expected to be 3 to 5 days
Secondary outcome [4] 0 0
Range of Passive Flexion
Timepoint [4] 0 0
Days 1-3
Secondary outcome [5] 0 0
Range of Active Flexion
Timepoint [5] 0 0
Days 1-3
Secondary outcome [6] 0 0
Perioperative Fluid Administration
Timepoint [6] 0 0
Day 1

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
Sex
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
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/12/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/03/2016
Sample size
Target
Accrual to date
Final
150
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, MBChB, MD (Thesis), EdD, FACS, FRACS
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
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
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

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


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT02278263