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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] 290482 0
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 300860 0
Condition category
Condition code
Surgery 300680 300680 0 0
Other surgery
Injuries and Accidents 302061 302061 0 0
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] 296340 0
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] 300102 0
Incidence of acute postoperative blood transfusion in patients presenting with intra capsular neck of femur fractures undergoing hemiarthroplasty or total hip arthroplasty.
Timepoint [1] 300102 0
Within seven days of administration of Tranexamic acid.
Secondary outcome [1] 329048 0
Incidence of acute post-operative deep vein thrombosis (DVT) which will be assessed with a bilateral lower limb doppler ultrasound.
Timepoint [1] 329048 0
Day seven post administration of Tranexamic acid
Secondary outcome [2] 332821 0
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] 332821 0
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?
No
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] 7681 0
Nepean Hospital - Kingswood
Recruitment postcode(s) [1] 15599 0
2747 - Kingswood

Funding & Sponsors
Funding source category [1] 295927 0
Hospital
Name [1] 295927 0
Orthopaedic Department, Nepean Hospital
Country [1] 295927 0
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] 294801 0
None
Name [1] 294801 0
Address [1] 294801 0
Country [1] 294801 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297204 0
Nepean Blue Mountain Local Health District HREC
Ethics committee address [1] 297204 0
NBMLHDHREC
Nepean Hospital
Derby Street
Kingswood, NSW 2747
Ethics committee country [1] 297204 0
Australia
Date submitted for ethics approval [1] 297204 0
17/11/2014
Approval date [1] 297204 0
22/02/2017
Ethics approval number [1] 297204 0
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 70190 0
Dr Yasser Khatib
Address 70190 0
Orthopaedic Surgeon
Nepean Hospital (NBMLHD)
2 Hope St
Penrith, NSW 2750
PO box 949, Penrith, NSW 2750
Country 70190 0
Australia
Phone 70190 0
+61 2 4721 4434
Fax 70190 0
+61 2 4732 3155
Email 70190 0
[email protected]
Contact person for public queries
Name 70191 0
Yasser Khatib
Address 70191 0
Orthopaedic Surgeon
Nepean Hospital (NBMLHD)
2 Hope St
Penrith, NSW 2750
PO box 949, Penrith, NSW 2750
Country 70191 0
Australia
Phone 70191 0
+61 2 4721 4434
Fax 70191 0
+61 2 4732 3155
Email 70191 0
[email protected]
Contact person for scientific queries
Name 70192 0
Yasser Khatib
Address 70192 0
Orthopaedic Surgeon
Nepean Hospital (NBMLHD)
2 Hope St
Penrith, NSW 2750
PO box 949, Penrith, NSW 2750
Country 70192 0
Australia
Phone 70192 0
+61 2 4721 4434
Fax 70192 0
+61 2 4732 3155
Email 70192 0
[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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