Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000907448
Ethics application status
Approved
Date submitted
29/06/2016
Date registered
8/07/2016
Date last updated
14/06/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
Tranexamic acid Trial Intravenous versus Intra articular Tranexamic acid in Primary Hip Arthroplasty: A Prospective Randomised Double Blinded non Inferiority Trial
Scientific title
Effect of Intravenous versus Intra articular Tranexamic acid on haemoglobin levels in patients undergoing primary Hip Arthroplasty A randomised Double blinded non inferiority trial. .
Secondary ID [1] 289628 0
NONE
Secondary ID [2] 289629 0
NONE
Universal Trial Number (UTN)
U1111-1184-8157
Trial acronym
Tranexamic acid in Hip study IV versus Intra articular.
TAHIVIA
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Osteoarthritis 299306 0
Condition category
Condition code
Surgery 299299 299299 0 0
Surgical techniques
Musculoskeletal 299317 299317 0 0
Osteoarthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
At Induction patients are randomised into Group A or B.
Group A 15mg /kg IV infusion of Tranexamic acid given IV at induction and then at 8 hours and 16 hours post surgery.
Group B Intra articular dose of Tranexamic acid given in 40 mls of Normal Saline at 15mg.kg into the capsule prior to skin closure then followed by Normal Saline 100mls at 8 and 16 hours post surgery.
Intervention code [1] 295177 0
Treatment: Drugs
Comparator / control treatment
This is a site control either IV or intra articular using equivalent dose.
Control group
Active

Outcomes
Primary outcome [1] 298792 0
Change in Haemaglobin pre surgery and day 1 post surgery using normal pathology conducted Completed Blood Count assay.
Timepoint [1] 298792 0
1 week prior to surgery and 24 hours post surgery.
Primary outcome [2] 298867 0
Number of transfusions, assessed by review of medical record.
Timepoint [2] 298867 0
24hours post surgery
Primary outcome [3] 298868 0
DVT symptoms, any infections
Timepoint [3] 298868 0
Clinic visit at 6 weeks post surgery, phone contact at 90 days post surgery.
Secondary outcome [1] 325216 0
Days recorded of hospital stay electronically recorded by admission to discharge date
Timepoint [1] 325216 0
Discharge day

Eligibility
Key inclusion criteria
Primary Hip arthroplasty due to osteoarthritis
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Pregnant and lactating women.
Renal Impairment (Creatinine> 120mmol/L)
Active intravascular clotting or DVT tendencies.
Cognitive impairment.
Hypersensitivity to Tranexamic acid.

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 with numbered allocations using a digital randomised computer generated allocation Research staff blinded to which group patient would be allocated.
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 administering the treatment/s

Intervention assignment
Parallel
Other design features
Phase
Phase 3 / Phase 4
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Summary statistics comparing the two groups using continuous variables and one way analysis with p value of <0.05 considered. For a haemoglobin non inferiority margin of 5g/L a minimum of 85 patients are required per group to achieve 90% power.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
17/06/2016
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
85
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 6045 0
Calvary Wakefield Hospital - Adelaide
Recruitment postcode(s) [1] 13499 0
5000 - Adelaide

Funding & Sponsors
Funding source category [1] 293957 0
Other
Name [1] 293957 0
Wakefield Orthopaedic Clinic
Country [1] 293957 0
Australia
Primary sponsor type
Individual
Name
David Campbell
Address
Wakefield Orthopaedic Clinic, 270 Wakefield St L2 Adelaide SA 5000
Country
Australia
Secondary sponsor category [1] 292775 0
None
Name [1] 292775 0
Address [1] 292775 0
Country [1] 292775 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295377 0
Calvary Health Care Ethics Committee
Ethics committee address [1] 295377 0
89 Strangways Tce North Adelaide 5006 South Australia
Ethics committee country [1] 295377 0
Australia
Date submitted for ethics approval [1] 295377 0
25/03/2016
Approval date [1] 295377 0
15/04/2016
Ethics approval number [1] 295377 0
16 CHREC-F001

Summary
Brief summary
This is a randomised study to determine dosing methods of administering Tranexamic acid a drug used to reduce bleeding in Hip replacement surgery. The purpose of the study is to determine if the drug is as effective giving it via Intravenous route or Intra articular route direct into the hip capsule.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 67042 0
Prof David Campbell
Address 67042 0
Wakefield Orthopaedic Clinic, 270 Wakefield St L2,
Adelaide
South Australia 5000
Country 67042 0
Australia
Phone 67042 0
+ 61 882364128
Fax 67042 0
Email 67042 0
[email protected]
Contact person for public queries
Name 67043 0
Ms christine schutz
Address 67043 0
Wakefield Orthopaedic Clinic
270 Wakefield St L2,
Adelaide 5000
SA
Country 67043 0
Australia
Phone 67043 0
+61 882364128
Fax 67043 0
Email 67043 0
[email protected]
Contact person for scientific queries
Name 67044 0
Ms christine schutz
Address 67044 0
Wakefield Orthopaedic Clinic
270 Wakefield St L2 ,
Adelaide
SA 5000
Country 67044 0
Australia
Phone 67044 0
+61 882364128
Fax 67044 0
Email 67044 0
[email protected]

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
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.