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Trial registered on ANZCTR


Registration number
ACTRN12617000918325
Ethics application status
Approved
Date submitted
10/06/2017
Date registered
22/06/2017
Date last updated
4/06/2019
Date data sharing statement initially provided
4/06/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
In patients having shoulder replacement surgeries, is there any difference in giving tranexamic acid orally or intravenously for minimising bleeding during surgery?
Scientific title
A Prospective Randomised Blinded Controlled Trial Comparing Oral vs Intravenous Administration of Tranexamic Acid in Total Anatomic and Reverse Shoulder Arthroplasty.
Secondary ID [1] 292166 0
Nil known
Universal Trial Number (UTN)
u1111-1194-6688
Trial acronym
The SANTA Trial (Shoulder Arthroplasty Necessitating Tranexamic Acid)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Shoulder Arthritis 303607 0
Osteoarthritis 303608 0
Condition category
Condition code
Musculoskeletal 303020 303020 0 0
Osteoarthritis
Surgery 303090 303090 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention: Tranexamic Acid (TXA)
Intravenous TXA group:
1. Two hours prior to the surgical procedure, four placebo tablets (vitamin tablet) is given orally to the patient.
2. Following induction of anaesthesia, 1.5g of TXA is given intravenously with 10mLs of normal saline solution as a bolus. The half life of TXA is 2 hours. Therefore, repeated dosing during surgery is not required.

Oral TXA group:
1. Two hours prior to the surgical procedure, 2g of TXA (4 tablets of 500mg each) is given orally to the patient.
2. Following induction of anaesthesia, 10mL of normal saline is injected intravenously as a bolus.


Adherence:
The intravenous drug/saline will be administered while the patient is asleep under anaesthesia. Therefore adherence will be 100%.
The oral drug/placebo will be administered by a nurse 2 hours prior to the procedure and the nurse will ensure the medications are taken by the patient.


Intervention code [1] 298317 0
Treatment: Drugs
Comparator / control treatment
Oral Tranexamic Acid compared with Intraveous Tranexamic Acid
Control group
Active

Outcomes
Primary outcome [1] 302398 0
Change in Haemoglobin.
This is defined as the preoperative haemoglobin minus the lowest postoperative haemoglobin.

Blood samples will be obtained to gain knowledge of the haemoglobin level (as part of the Full blood count analysis).
Timepoint [1] 302398 0
All patients will have routine pre-operative haemoglobin on the day of surgery and on each morning during hospital stay post surgery
Secondary outcome [1] 335846 0
Drain output as measured by the volume in the drain once it is removed on the morning of postoperative day one.
Timepoint [1] 335846 0
morning of the post operative day one.
Secondary outcome [2] 336116 0
Number of blood units transfused
Timepoint [2] 336116 0
As measured by going through clinical records. This is assessed during the operative period and throughout the patient's stay as inpatient following the shoulder arthroplasty.
Secondary outcome [3] 336117 0
Length of hospital stay as measured by going through clinical records
Timepoint [3] 336117 0
Assessed by going through hospital record at the time of hospital discharge.
Secondary outcome [4] 336118 0
Incidence of thromboembolic events
Timepoint [4] 336118 0
During the entire hospital stay.
Secondary outcome [5] 336119 0
Calculated blood loss using patient's blood test results before and after the operation during their hospital stay.
Timepoint [5] 336119 0
Determined during the patient's hospital stay from surgery completion until hospital discharge.
Secondary outcome [6] 336185 0
Calculated haemoglobin loss using patient's blood test results before and after the operation during their hospital stay.
Timepoint [6] 336185 0
Determined during the patient's hospital stay from surgery completion until hospital discharge.

Eligibility
Key inclusion criteria
Patients undergoing elective shoulder replacements for osteoarthritis
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients <18 years of age
Revision surgery
History of joint infection
History of bleeding or metabolic disorder
History of renal failure
History of renal transplant
History of myocardial infarction or stroke within the past year
Placement of an arterial stent within the past year
Preoperative haemoglobin level of <115g/L or haematocrit <35%
History of deep venous thrombosis (DVT) or pulmonary embolism (PE)
Patients unwilling to accept blood transfusion
Patients with allergy to TXA

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)
Sealed opaque envelopes
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)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
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 outside Australia
Country [1] 8962 0
New Zealand
State/province [1] 8962 0

Funding & Sponsors
Funding source category [1] 296699 0
Hospital
Name [1] 296699 0
Whangarei Hospital
Address [1] 296699 0
Department of Orthopaedic Surrgery
Whangarei Hospital
Maunu Road
Whangarei, 0148
Northland
New Zealand
Country [1] 296699 0
New Zealand
Primary sponsor type
Hospital
Name
Whangarei Hospital
Address
Department of Orthopaedic Surrgery
Whangarei Hospital
Maunu Road
Whangarei, 0148
Northland
New Zealand
Country
New Zealand
Secondary sponsor category [1] 295660 0
None
Name [1] 295660 0
Address [1] 295660 0
Country [1] 295660 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297929 0
New Zealand Health and Discibility Ethics Committee
Ethics committee address [1] 297929 0
Ministry of Health
Health and Disability Ethics Committees
PO Box 5013
Wellington 6140
Ethics committee country [1] 297929 0
New Zealand
Date submitted for ethics approval [1] 297929 0
13/04/2017
Approval date [1] 297929 0
09/06/2017
Ethics approval number [1] 297929 0
17/NTB/70

Summary
Brief summary
Tranexamic acid (TXA) functions to decrease blood loss by affecting the blood clotting system within the body. Perioperative administration of TXA in the context of shoulder arthroplasty has been shown to decrease perioperative blood loss compared to placebo in four studies. One prospective, randomised, controlled study (Vara et al, 2017) and two retrospective studies (Abildgaard et al, 2016; Friedman et al, 2016) demonstrated efficacy of intravenous TXA compared with placebo in reducing blood loss in shoulder arthroplasty. Furthermore, another prospective, randomised, controlled study showed efficacy of topical administration of 2g of TXA at the completion of the case compared with placebo (Gillespie et al, 2015). Recently, oral administration of TXA has been shown to be equally as effective for minimising blood loss following total hip arthroplasty (Kayupov et al, 2017). However, to our knowledge, there is no information in the literature comparing the difference in the route of administration of TXA in reducing blood loss following total shoulder arthroplasty. The aim of this study is to compare the efficacy of intravenous administration of TXA with oral infiltration of TXA in decreasing blood loss following total anatomic and reverse shoulder arthroplasties.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 75490 0
Dr Ryan Gao
Address 75490 0
Department of Orthopaedic Surgery
Whangarei Hospital, 0148
Northland
New Zealand
Country 75490 0
New Zealand
Phone 75490 0
+642102422213
Fax 75490 0
Email 75490 0
ygao921@gmail.com
Contact person for public queries
Name 75491 0
Dr Ryan Gao
Address 75491 0
Department of Orthopaedic Surgery
Whangarei Hospital, 0148
Northland
New Zealand
Country 75491 0
New Zealand
Phone 75491 0
+642102422213
Fax 75491 0
Email 75491 0
ygao921@gmail.com
Contact person for scientific queries
Name 75492 0
Dr Ryan Gao
Address 75492 0
Department of Orthopaedic Surgery
Whangarei Hospital, 0148
Northland
New Zealand
Country 75492 0
New Zealand
Phone 75492 0
+642102422213
Fax 75492 0
Email 75492 0
ygao921@gmail.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
De-identified data:
individual participant data underlying published results only
When will data be available (start and end dates)?
Immediately following publication, no end date
Available to whom?
only researchers who provide a methodologically sound proposal
Available for what types of analyses?
only to achieve the aims in the approved proposal
How or where can data be obtained?
access subject to approvals by Principal Investigator
What supporting documents are/will be available?
No other documents available
Summary results
No Results