ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12617000617369

Ethics application status

Approved

Date submitted

27/04/2017

Date registered

1/05/2017

Date last updated

25/09/2017

Type of registration

Prospectively registered

Titles & IDs

Public title

Oral tranexamic acid to reduce blood loss in patients undergoing total knee replacements

Scientific title

Oral tranexamic acid in the reduction of peri-operative blood loss in patients undergoing total knee replacements.

Secondary ID [1]

Nil known

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

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

Total knee replacement

Condition category

Condition code

Surgery

Other surgery

Blood

Other blood disorders

Musculoskeletal

Osteoarthritis

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

The study aims to demonstrate non-inferiority of oral tranexamic acid (TXA) compared to topical and intravenous in reducing blood loss during total knee replacement.
Study: 1g oral TXA 2hr prior to surgery, 1g oral TXA two hours post-surgery and a final 1g oral dose six hours post-surgery.
Patients will receive 2.5mg of oral apixaban twice daily for 15 days, commencing 8 hours post-surgery as prophylactic antithrombotic therapy.
Oral tranexamic acid will be administered under supervision of a health professional (eg nurse) at the times specified. The dose will be supervised to ensure adherence with administration noted on the drug chart. Apixaban adherence will be monitored via return of empty packets by patients.

Intervention code [1]

Treatment: Drugs

Comparator / control treatment

Control: 3g topical TXA perioperatively before surgical incision, 1g IV four hours post-surgery and a final 1g oral dose eight hours post-surgery.
Patients will receive 2.5mg of oral apixaban twice daily for 15 days, commencing 8 hours post-surgery as prophylactic antithrombotic therapy.
The first two doses of tranexamic acid will be administered by health professionals and the third oral dose under supervision of a health professional (eg nurse) at the time specified.
This oral dose will be supervised to ensure adherence with administration noted on the drug chart. Apixaban adherence will be monitored via return of empty packets by patients.

Control group

Active

Outcomes

Primary outcome [1]

The primary outcome will be blood loss due to surgery.

Timepoint [1]

This data will be determined by the amount of blood loss in theatre and the volume collected from the joint drain at ten hours post-surgery.

Secondary outcome [1]

Safety will be measured by the incidence of adverse events attributed to TXA, in particular the incidence of DVT.

Timepoint [1]

This will be determined by means of Doppler ultrasound at six weeks post-surgery.

Eligibility

Key inclusion criteria

Participants undergoing total knee replacements at John Flynn Hospital

Minimum age

18 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

Patients currently on anticoagulant therapy, patients with bleeding disorders, patients at high risk of deep vein thrombosis (i.e.Factor V Leiden, past history of deep vein thrombosis)

Study design

Purpose of the study

Treatment

Allocation to intervention

Non-randomised trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Quasi-randomisation allocation involving operation theatre allocation

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

Masking / blinding

Open (masking not used)

Who is / are masked / blinded?

Intervention assignment

Parallel

Other design features

Phase

Phase 2 / Phase 3

Type of endpoint/s

Safety/efficacy

Statistical methods / analysis

This study aims to have 25 participants in each arm of the study. This was based on 80% power, 95% confidence interval on the average blood loss from total knee replacements of 100-400mL.
Statistical analysis will be performed on GraphPad Instat Version 3 with patient characteristics reported as number and percentage for categorical data, mean+/-standard deviation or median and interquartile ranges for continuous data. Mean data will be used for analysis and comparison using ordinary analysis of variance through non-parametric methods, including Mann-Whitney test for univariate analysis and Dunn’s multiple comparisons test for bivariate analysis. Significance will be defined as* p<0.05, **p<0.01, and ***p<0.001, and graphing performed with GraphPad Prism 6.
.

Recruitment

Recruitment status

Recruiting

Date of first participant enrolment

Anticipated

17/07/2017

Actual

28/08/2017

Date of last participant enrolment

Anticipated

30/10/2017

Actual

Date of last data collection

Anticipated

Actual

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

QLD

Recruitment hospital [1]

John Flynn - Gold Coast Private Hospital - Tugun

Recruitment postcode(s) [1]

4224 - Tugun

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

John Flynn Private Hospital

Address [1]

42 Inland Drive Tugun Queensland 4222

Country [1]

Australia

Funding source category [2]

University

Name [2]

Griffith University

Address [2]

School of Pharmacy, Griffith University, Gold Coast Campus
58 Parklands Drive Southport Queensland 4215

Country [2]

Australia

Primary sponsor type

Hospital

Name

John Flynn Private Hospital

Address

42 Inland Drive Tugun Queensland 4222

Country

Australia

Secondary sponsor category [1]

University

Name [1]

Griffith University

Address [1]

School of Pharmacy, Griffith University, Gold Coast Campus
58 Parklands Drive Southport Queesland 4215

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Greenslopes Research and Ethics Commitee

Ethics committee address [1]

Greenslopes Private Hospital
Newdegate Street Greenslopes Queensland 4120

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

26/04/2017

Approval date [1]

06/07/2017

Ethics approval number [1]

Protocol 17/25

Ethics committee name [2]

Griffith University

Ethics committee address [2]

42 Parklands Drive Southport 4222

Ethics committee country [2]

Australia

Date submitted for ethics approval [2]

06/07/2017

Approval date [2]

10/07/2017

Ethics approval number [2]

2017/541

Summary

Brief summary

Background and Significance
Evidence supporting the use of tranexamic acid (TXA) in large joint replacements to reduce blood loss and the need for transfusion has been available for many years. To date evidence supports the use of topical or intravenous (IV) TXA, with a recent meta-analysis concluding that the two produced similar effects in the reduction of blood loss due to surgery. Very few studies have investigated the possibility of the use of oral TXA in place of topical/IV. The use of oral TXA has the potential to provide significant financial savings to healthcare facilities, with equivalent quantities of IV TXA ampoules being almost 40-fold more expensive than oral tablets. 
Aim and method
This study aims to identify the non-inferiority of oral TXA in the reduction of peri-operative blood loss when compared to a topical/IV regimen in patients undergoing total knee replacements (TKR). In addition, the effect of pre-operative TXA on surgical blood-loss or total blood loss will be examined, in comparison to post-operative. The study will also investigate safety by incidence of deep vein thrombosis (DVT).  
The study will comprise of two arms, a study arm which will be treated with and oral TXA regimen and a control arm that will be treated with a currently used topical/IV TXA regimens. The TXA treatment regimens will be as follows:
	Study:  1g oral TXA 2hr prior to surgery, 1g oral TXA two hours post-surgery and a final 1g oral dose six hours post-surgery.
	Control: 3g topical TXA perioperatively, 1g IV four hours post-surgery and a final 1g oral dose eight hours post-surgery.
Both groups will receive 2.5mg of oral apixaban twice daily for 15 days, commencing 8 hours post-surgery as prophylactic antithrombotic therapy.
All procedures will be conducted by the same orthopaedic surgeon and the anaesthetist for the study arm will remain constant throughout.
The primary outcome will be blood loss due to surgery. This data will be determined by the amount of blood loss in theatre and the volume collected from the joint drain at ten hours post-surgery. Safety will be measured by the incidence of adverse events attributed to TXA, in particular the incidence of DVT. This will be determined by means of Doppler ultrasound at six weeks post-surgery.
Duration and participants
The study will be ongoing with an aim of gathering approximately 50 participants in total, i.e. 25 participants per arm.
All data will be collected from patients undergoing TKRs at John Flynn Private Hospital, all of which will be conducted by the same orthopaedic surgeon. Patients will be excluded if they require adjustments in the TXA regimen or changes to prophylactic antithrombotic therapy. Patient’s will also be excluded if they are undergoing a TKR revision.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Mr Liam King

Address

Pharmacy Department, Ramsay Health Care
John Flynn Private Hospital
42 Inland Drive Tugun Queensland 4224

Country

Australia

Phone

+61 7 5598 9155

Fax

kingliam@ramsayhealth.com.au

Contact person for public queries

Name

Liam King

Address

John Flynn Private Hospital
42 Inland Drive Tugun Queensland 4224

Country

Australia

Phone

+61 7 5598 0094

Fax

kingliam@ramsayhealth.com.au

Contact person for scientific queries

Name

Nijole Bernaitis

Address

School of Pharmacy, Griffith University, Gold Coast Campus
58 Parklands Drive Southport Queensland 4215

Country

Australia

Phone

+61 7 5552 9742

Fax

n.bernaitis@griffith.edu.au

No information has been provided regarding IPD availability

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
Study results article	Yes		"Comparison of oral vs. combined topical/intraveno... [More Details]
Conference poster	No		Poster presentation at Society of Hospital Pharmac... [More Details]

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	Comparison of oral vs. combined topical/intravenous/oral tranexamic acid in the prevention of blood loss in total knee arthroplasty: A randomised clinical trial.	2019	https://dx.doi.org/10.1016/j.otsr.2019.06.008

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

Trial Review

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Documents added manually

Documents added automatically