ANZCTR - Registration

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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

21/07/2020

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]

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

Osteoarthritis

Condition category

Condition code

Musculoskeletal

Osteoarthritis

Surgery

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]

Treatment: Drugs

Comparator / control treatment

Oral Tranexamic Acid compared with Intraveous Tranexamic Acid

Control group

Active

Outcomes

Primary outcome [1]

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]

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]

Drain output as measured by the volume in the drain once it is removed on the morning of postoperative day one.

Timepoint [1]

morning of the post operative day one.

Secondary outcome [2]

Number of blood units transfused

Timepoint [2]

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]

Length of hospital stay as measured by going through clinical records

Timepoint [3]

Assessed by going through hospital record at the time of hospital discharge.

Secondary outcome [4]

Incidence of thromboembolic events

Timepoint [4]

During the entire hospital stay.

Secondary outcome [5]

Calculated blood loss using patient's blood test results before and after the operation during their hospital stay.

Timepoint [5]

Determined during the patient's hospital stay from surgery completion until hospital discharge.

Secondary outcome [6]

Calculated haemoglobin loss using patient's blood test results before and after the operation during their hospital stay.

Timepoint [6]

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

Sex

Both males and females

Can healthy volunteers participate?

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

3/07/2017

Actual

29/08/2017

Date of last participant enrolment

Anticipated

31/12/2020

Actual

Date of last data collection

Anticipated

31/12/2020

Actual

Sample size

Target

Accrual to date

Final

Recruitment outside Australia

Country [1]

New Zealand

State/province [1]

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Whangarei Hospital

Address [1]

Department of Orthopaedic Surrgery
Whangarei Hospital
Maunu Road
Whangarei, 0148
Northland
New Zealand

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

New Zealand Health and Discibility Ethics Committee

Ethics committee address [1]

Ministry of Health
Health and Disability Ethics Committees
PO Box 5013
Wellington 6140

Ethics committee country [1]

New Zealand

Date submitted for ethics approval [1]

13/04/2017

Approval date [1]

09/06/2017

Ethics approval number [1]

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

Dr Ryan Gao

Address

Department of Orthopaedic Surgery
Whangarei Hospital, 0148
Northland
New Zealand

Country

New Zealand

Phone

+642102422213

Fax

ygao921@gmail.com

Contact person for public queries

Name

Ryan Gao

Address

Department of Orthopaedic Surgery
Whangarei Hospital, 0148
Northland
New Zealand

Country

New Zealand

Phone

+642102422213

Fax

ygao921@gmail.com

Contact person for scientific queries

Name

Ryan Gao

Address

Department of Orthopaedic Surgery
Whangarei Hospital, 0148
Northland
New Zealand

Country

New Zealand

Phone

+642102422213

Fax

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 Supporting Document Provided

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	Oral and intravenous tranexamic acid are equivalent at reducing blood loss following shoulder arthroplasty-A multicenter, double-blinded, randomized, placebo-controlled trial.	2022	https://dx.doi.org/10.1053/j.sart.2021.12.006

N.B. These documents automatically identified may not have been verified by the study sponsor.

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Documents added manually

Documents added automatically