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Trial registered on ANZCTR

Registration number

ACTRN12617000391370

Ethics application status

Approved

Date submitted

14/03/2017

Date registered

16/03/2017

Date last updated

23/01/2020

Date data sharing statement initially provided

21/01/2019

Type of registration

Prospectively registered

Titles & IDs

Public title

'Role of Tranexamic acid on blood loss in hip fracture patients'

Scientific title

Role of Tranexamic acid on post operative blood loss and blood transfusion in intra capsular neck of femur fracture patients undergoing hip arthroplasty (total hip arthroplasty or hemiarthroplasty)

Secondary ID [1]

None

Universal Trial Number (UTN)

U1111-1189-6122

Trial acronym

ROTANOF

Linked study record

Health condition

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

Intra capsular neck of femur fractures

Condition category

Condition code

Surgery

Other surgery

Injuries and Accidents

Fractures

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Intervention group - Patients presenting with intra-capsular neck of femur fractures undergoing arthroplasty (Total hip or hemiarthroplasty) will be administered intravenous Tranexamic acid in three doses (15mg/kg). First dose will be administered at the time of induction and remaining two at post operative eight and sixteen hours.

Intervention code [1]

Treatment: Drugs

Comparator / control treatment

Control group - Patients with intra capsular neck of femur fractures requiring total hip or hemiarthroplasty. The control group will not be administered Tranexamic acid or any blood loss medications as compared to intervention group which will be administered intravenous Tranexamic acid in three doses.

Control group

Active

Outcomes

Primary outcome [1]

Incidence of acute postoperative blood transfusion in patients presenting with intra capsular neck of femur fractures undergoing hemiarthroplasty or total hip arthroplasty.

Timepoint [1]

Within seven days of administration of Tranexamic acid.

Secondary outcome [1]

Incidence of acute post-operative deep vein thrombosis (DVT) which will be assessed with a bilateral lower limb doppler ultrasound.

Timepoint [1]

Day seven post administration of Tranexamic acid

Secondary outcome [2]

To assess whether the administration of TA in a three-dose intravenous protocol leads to a reduction in post-operative drop in Haemoglobin in the study population.

Timepoint [2]

Hb check on post op day 1,3 and 5.

Eligibility

Key inclusion criteria

Patients with intra-capsular neck of femur fractures undergoing hemiarthroplasty (cemented or uncemented) or total hip arthroplasty (cemented, hybrid or uncemented) within 48 hrs from the time of injury.

Minimum age

18 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

1.Neck of femur fractures requiring fixation by other methods e.g. by cannulated screws, dynamic hip screw or intra-medullary nail device.
2.Patients presenting 48 hours from the time of injury. This includes patients transferred to Nepean hospital from other hospitals.
3.Contra-indication to the administration of TA -
Previous history of thrombosis
Active thromboembolic disease (DVT,PE and cerebral thrombosis)
Other contraindication to the use of TA :
Patients with acquired disturbances of colour vision
Patients with subarachnoid haemorrhage
Previous history of seizure
Creatinine clearance < 30ml/min
Hypersensitivity to TA
4.Patients who are unable to provide informed consent.

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)

Allocation concealment is done with the help of central randomisation done 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 administering the treatment/s
The people assessing the outcomes

Intervention assignment

Parallel

Other design features

Phase

Phase 2

Type of endpoint/s

Safety/efficacy

Statistical methods / analysis

Based on 80% power to detect the minimum clinically important difference of 20% at a significant level of 0.05, 103 patients are required in each group. Allowing for 20% loss to follow up, we aim to recruit 125 patients. The minimum clinically important difference (MCID) of 20% we consider this difference to be necessary in order to justify the additional cost of TA.
Intention to treat analysis will be performed in the primary analysis. A senior statistician will conduct all statistical analysis.

Recruitment

Recruitment status

Recruiting

Date of first participant enrolment

Anticipated

27/03/2017

Actual

21/03/2017

Date of last participant enrolment

Anticipated

30/06/2020

Actual

Date of last data collection

Anticipated

30/07/2020

Actual

Sample size

Target

250

Accrual to date

161

Final

Recruitment in Australia

Recruitment state(s)

NSW

Recruitment hospital [1]

Nepean Hospital - Kingswood

Recruitment postcode(s) [1]

2747 - Kingswood

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Orthopaedic Department, Nepean Hospital

Address [1]

Nepean Hospital
Derby Street
Kingswood, NSW 2747

Country [1]

Australia

Primary sponsor type

Hospital

Name

Nepean Hospital (Nepean Blue Mountain Local Health District)

Address

Nepean Hospital
Derby Street
Kingswood, NSW, 2747

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Nepean Blue Mountain Local Health District HREC

Ethics committee address [1]

NBMLHDHREC
Nepean Hospital
Derby Street
Kingswood, NSW 2747

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

17/11/2014

Approval date [1]

22/02/2017

Ethics approval number [1]

HREC/14/Nepean 114 (Local reference 14/57)

Summary

Brief summary

The purpose is to investigate the role of tranexamic acid (TA) in the setting of intra-capsular neck of femur fractures which is the type of broken hip. (TA) is a medicine (synthetic type of amino acid lysine) which is used to prevent excessive blood loss during surgery. (TA) is commonly used in elective joint replacement (Total hip and total knee replacement) and is recognized to reduce blood loss during surgery and the need of blood transfusion afterward. However we do not have as much evidence on its effect in the setting of broken bone in hip. We intend to explore the relationship between its use and blood loss after surgery and the need for blood transfusion.
If the patient agrees to participate in this study, they will be asked to sign the Person Responsible Consent Form. This study will be conducted over 1 to 2 years.
The treatment being investigated in this study is three doses of (TA) given intravenously at the time of surgery and 8 and 16 hours after surgery. 
 Study participants are put into two groups and given different treatments, and the results are compared to see whether one treatment is better. To ensure the groups are similar to start with, a computer allocates each study participant into a group randomly, Neither the doctor nor the study participant can decide which treatment the participant receives.
Once the patient agrees to participate in this trial, they will then be randomly allocated a number which decides whether they receive either 3 doses of (TA) (intervention group) or not. The first dose is given at the time of surgery and next two 8 and 16 hours post surgery.
Study hypothesis
  1.	Administration of intravenous TA in patients presenting with intra-capsular neck of femur fractures undergoing hemiarthroplasty or total hip arthroplasty reduces the rate of post-operative blood loss and blood transfusion. 
2.	The intravenous administration of TA is safe and is not associated with an increase in the rates of post-operative venous thromboembolic, cardiovascular or cerebrovascular events in this population.
Aims
This study aims to provide high quality evidence of the relative benefits and risks of the use of TA in the setting of emergency hemiarthroplasty or THA for the management of NOF fractures.  The results of this study will support and influence the future treatment of this common injury.
Primary outcome
1.	To determine the effect of administration of a three dose protocol of intravenous TA on the incidence of acute postoperative blood transfusion in patients presenting with intra capsular neck of femur fractures undergoing hemi or THA
Secondary outcomes
1.To assess the incidence of acute post-operative venous thromboembolic (deep vein thrombosis, pulmonary embolism), cardiovascular (acute myocardial infarction) and cerebrovascular events (stroke) in this study population
2.To assess whether the administration of TA in a three-dose intravenous protocol leads to a reduction in post-operative drop in Haemoglobin.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr Yasser Khatib

Address

Orthopaedic Surgeon
Nepean Hospital (NBMLHD)
2 Hope St
Penrith, NSW 2750
PO box 949, Penrith, NSW 2750

Country

Australia

Phone

+61 2 4721 4434

Fax

+61 2 4732 3155

[email protected]

Contact person for public queries

Name

Yasser Khatib

Address

Orthopaedic Surgeon
Nepean Hospital (NBMLHD)
2 Hope St
Penrith, NSW 2750
PO box 949, Penrith, NSW 2750

Country

Australia

Phone

+61 2 4721 4434

Fax

+61 2 4732 3155

[email protected]

Contact person for scientific queries

Name

Yasser Khatib

Address

Orthopaedic Surgeon
Nepean Hospital (NBMLHD)
2 Hope St
Penrith, NSW 2750
PO box 949, Penrith, NSW 2750

Country

Australia

Phone

+61 2 4721 4434

Fax

+61 2 4732 3155

[email protected]

Data sharing statement

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

Yes

What data in particular will be shared?

The data will include, the diagnosis, the treatment given , post operative haemoglobin and any complications. The data will be available in de-identified manner.

When will data be available (start and end dates)?

The data will be available at the completion of trial for five years.

Available to whom?

Only researchers who provide a methodologically sound proposal

Available for what types of analyses?

To achieve the aims in the approved proposal, for IPD meta-analyses

How or where can data be obtained?

Access subject to approvals by Principal Investigator with prior requirement to sign data access agreement

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

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No documents have been uploaded by study researchers.

Documents added automatically

No additional documents have been identified.

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