ANZCTR - Registration

Did you know?

The ANZCTR now automatically displays published trial results and simplifies the addition of trial documents such as unpublished protocols and statistical analysis plans.

These enhancements will offer a more comprehensive view of trials, regardless of whether their results are positive, negative, or inconclusive.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers

Trial registered on ANZCTR

Registration number

ACTRN12616000723482

Ethics application status

Approved

Date submitted

27/05/2016

Date registered

1/06/2016

Date last updated

28/11/2018

Date data sharing statement initially provided

28/11/2018

Date results provided

28/11/2018

Type of registration

Prospectively registered

Titles & IDs

Public title

Intravenous tranexamic acid ("TXA") and its effect on operating conditions, blood loss, post-operative pain and complications in patients undergoing total shoulder replacement.

Scientific title

Effect of systemic tranexamic acid use on operating conditions, blood loss, post-operative pain and complications in patients undergoing shoulder arthroplasty.

Secondary ID [1]

None

Universal Trial Number (UTN)

U1111-1183-3447

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Blood loss in total shoulder arthroplasty

Condition category

Condition code

Musculoskeletal

Osteoarthritis

Surgery

Other surgery

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Group 1 (TXA group) will receive 2000mg (20ml) of Tranexamic Acid (TXA) intravenously 5 minutes before incision.

Intervention code [1]

Treatment: Drugs

Comparator / control treatment

Group 2 (Control group) will receive 2000mg (20ml) of Saline intravenously 5 minutes before incision..

Control group

Placebo

Outcomes

Primary outcome [1]

Change in haemaglobin level as measured by the difference between pre-operative and post-operative levels as assessed by serum assay.

Timepoint [1]

Pre-operative haemaglobin will be assessed the day before operation. Post-operative haemaglobin will be assessed in the morning of the first day after operation.

Primary outcome [2]

Change in haemocrit as measured by the difference between pre-operative and post-operative levels as assessed by serum assay.

Timepoint [2]

Pre-operative haemocrit will be assessed the day before operation. Post-operative haemocrit will be assessed in the morning of the first day after operation.

Secondary outcome [1]

Operative time defined as time from induction of anaesthesia until wound closure as timed by surgical assistant with stopwatch.

Timepoint [1]

Operative time will be calculated at the conclusion of the operation (day 0).

Secondary outcome [2]

Transfusion requirement as measured by data linkage to patient medical records.

Timepoint [2]

Within 6 weeks after intervention commencement.

Secondary outcome [3]

Pain assessment using visual analogue score.

Timepoint [3]

Measured daily for 5 days starting from 24 hours after operation.

Secondary outcome [4]

Passive shoulder range of motion by using a goniometer.

Timepoint [4]

Day 3, 2 weeks and 8 weeks post operation.

Secondary outcome [5]

Infection rates as measured by data linkage to patient medical records.

Timepoint [5]

Within 6 weeks after intervention commencement.

Secondary outcome [6]

Thromboembolic adverse events as measured by data linkage to patient medical records.

Timepoint [6]

Within 6 weeks after intervention commencement.

Secondary outcome [7]

Procedure complexity rating as measured by the operating surgeon selecting either "more complex than usual", "as usual" or "less complex than usual" on a checklist.

Timepoint [7]

At the conclusion of the operation.

Secondary outcome [8]

Operative field visibility rating as measured by the operating surgeon selecting either "excellent", "good", "fair"or "poor" on a checklist.

Timepoint [8]

At the conclusion of the operation.

Secondary outcome [9]

Drain output measured in cc.

Timepoint [9]

8 hours post operation, 16 hours post operation and 24 hours post operation.

Secondary outcome [10]

Post-operative haematoma occurrence as measured by data linkage to patient medical records.

Timepoint [10]

Within 24 hours post operation.

Secondary outcome [11]

Time spent in recovery room as measured by the difference between time of arrival to time of departure.

Timepoint [11]

Time of departure from recovery room.

Secondary outcome [12]

Time spent in hospital as measured by the difference between date of admission to date of discharge.

Timepoint [12]

Date of discharge.

Eligibility

Key inclusion criteria

1. Patients who have consented for anatomic or reverse shoulder arthroplasty under one of the principal investigators.
2. Patients who are capable of and have given informed consent for their participation in this study.

Minimum age

18 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

1. Patients allergic to tranexamic acid
2. Patients with a failed arthroplasty requiring revision
3. Patients with history of deep venous thrombosis or pulmonary embolism
4. Patients with cardiovascular disease, including coronary disease or peripheral arteriopathy
5. Patients with renal or liver failure
6. Patients with a known coagulopathy
7. Patients that refuse a potential transfusion

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)

Central randomisation by computer.

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation).

Masking / blinding

Blinded (masking used)

Who is / are masked / blinded?

The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data

Intervention assignment

Parallel

Other design features

None.

Phase

Phase 4

Type of endpoint/s

Efficacy

Statistical methods / analysis

Sample size was calculated based on the primary objective. It was decided to replicate work done by Gillespie et al (2015) who found an average change in haemaglobin level of 2.6g/dL in the placebo group and 1.7g/dL in the TXA group (p < .001) with 111 patients. It was decided that increasing the subjects from 111 to 150 patients might improve the power of the study.

Correlation analysis, including univariate and multivariate analyses will be used to determine the correlation between systemic administration of TXA and the selected outcome criteria. Subgroup analysis will be carried between the different types of prosthesis (reverse versus anatomic). P value <0.5 will be considered as statistically significant. All data will be entered into Socrates Orthopaedic Outcomes Software (Ortholink Pty Ltd, Sydney, Australia).

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

31/10/2016

Actual

17/10/2016

Date of last participant enrolment

Anticipated

28/04/2017

Actual

25/08/2017

Date of last data collection

Anticipated

Actual

19/10/2017

Sample size

Target

150

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

NSW

Recruitment hospital [1]

North Shore Private Hospital - St Leonards

Recruitment hospital [2]

Mater Sydney - North Sydney

Recruitment hospital [3]

Royal North Shore Hospital - St Leonards

Recruitment postcode(s) [1]

2065 - St Leonards

Recruitment postcode(s) [2]

2060 - North Sydney

Recruitment postcode(s) [3]

2065 - Royal North Shore Hospital

Funding & Sponsors

Funding source category [1]

Other Collaborative groups

Name [1]

Sydney Shoulder Research Institute

Address [1]

Suite 201
Level 2
156 Pacific Highway
St Leonards NSW 2065

Country [1]

Australia

Primary sponsor type

Individual

Name

Dr Benjamin Cass

Address

Sydney Shoulder Research Institute
Suite 201
Level 2
156 Pacific Highway
St Leonards NSW 2065

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

North Shore Private Hospital Ethics Committee

Ethics committee address [1]

North Shore Private Hospital
Westbourne Street
St Leonards   NSW   2065

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

11/04/2016

Approval date [1]

25/10/2016

Ethics approval number [1]

Ethics committee name [2]

St Vincent's Hospital Sydney Human Research Ethics Committee

Ethics committee address [2]

Research Office
Level 6, de Lacy Building
St Vincent's Hospital
390 Victoria Street
Darlinghurst   NSW   2010

Ethics committee country [2]

Australia

Date submitted for ethics approval [2]

11/05/2016

Approval date [2]

13/09/2016

Ethics approval number [2]

Summary

Brief summary

This was a multicentre multisurgeon prospective doubleblinded randomized and controlled trial looking at the effectiveness of single dose intravenous administration of Tranexamic Acid (TXA) in patients undergoing shoulder arthroplasty.

The aim of this study was to extend Level I category evidence of the known benefits of TXA to shoulder arthroplasty. The primary objective of this study was to test the hypothesis that systemic use of Tranexamic acid improves operating conditions, decreases blood loss, postoperative pain and complications such as haematoma and need for transfusion. The secondary objective was to carry out subgroup analysis between reverse and anatomical shoulder arthroplasty with the hypothesis that reverse causes more blood loss than anatomic.

All consecutive patients presenting to an elective orthopaedic consultation with a failed nonoperative management of shoulder arthritis indicated for shoulder arthroplasty were considered eligible for this study. After having been screened for inclusion and exclusion criteria, read the information sheet and signed the consent form, patients were blindly randomized to one of 2 groups: Systemic TXA or Control.

Patients’ general demographic characteristics such as age, sex, dominance, diagnosis, BMI, American Society of Anaesthesia (ASA) score and other relevant comorbidities were collected in a deidentified database locked on a password-protected computer. 

During the surgery, patients were administered either 2mg of intravenous TXA or a placebo equivalent (saline solution). Analysed outcome variables included: surgeon’s rating of surgical field visibility and overall appreciation of the complexity of the procedure, operative time, pre- and postoperative haemoglobin and haematocrit levels, drain output at 6,12 and 24 hours, need for transfusion, occurrence of postoperative haematoma, postoperative pain Visual Analog Scale (pVAS), time spent in recovery room and hospital room.

Trial website

http://www.ssri.net.au/research/txa-study/

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr Benjamin Cass

Address

Sydney Shoulder Research Institute
Suite 201, Level 2
156 Pacific Highway
St Leonards NSW 2065

Country

Australia

Phone

+61 2 9460 8888

Fax

+61 2 9460 6064

cassadmin@sydneyshoulder.com.au

Contact person for public queries

Name

Jasmin Gwynne

Address

Sydney Shoulder Research Institute
Suite 201, Level 2
156 Pacific Highway
St Leonards NSW 2065

Country

Australia

Phone

+61 2 9460 8813

Fax

+61 2 9460 6064

jasmin@sydneyshoulder.com.au

Contact person for scientific queries

Name

Benjamin Cass

Address

Sydney Shoulder Research Institute
Suite 201, Level 2
156 Pacific Highway
St Leonards NSW 2065

Country

Australia

Phone

+61 2 9460 8888

Fax

+61 2 9460 6064

cassadmin@sydneyshoulder.com.au

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

Now that analysis has been completed, all study data has been deidentified, stored confidentially and will not be used for any further research unless further ethics approval is granted.

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

Documents added manually

Type	Is Peer Reviewed?	DOI	Citations or Other Details	Attachment
Basic results	No			370797-(Uploaded-23-11-2018-13-34-36)-Basic results summary.docx
Plain language summary	No		Our results show that a single dose of tranexamic ... [More Details]

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	A single dose of tranexamic acid reduces blood loss after reverse and anatomic shoulder arthroplasty: a randomized controlled trial.	2021	https://dx.doi.org/10.1016/j.jse.2020.11.022

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

Trial Review

Did you know?

Documents added manually

Documents added automatically