None listed
Conditions
Brief summary
Does tranexamic acid use in the perioperative period reduce post operative thigh swelling, improve short term functional outcomes and reduce analgesia use following total hip replacement? The secondary question of whether tranexamic acid use decreases blood loss in the anterior approach to total hip replacements will also be addressed.
Interventions
Patients will be randomly assigned to the control or experiment arm of the study by the pharmacist who will have a random sequence to dictate arm allocation. Those in the intervention arm will receive one 15mg per Kg intraoperative bolus of tranexamic acid intravenously at the time of induction of anaesthesia. With a further 15mg / kg bolus at 8hrs and 16 hours post procedure. The procedure duration is approximately 1 hour. This is the current protocol being employed by Orthopaedic surgeons and
Patients will be randomly assigned to the control or experiment arm of the study by the pharmacist who will have a random sequence to dictate arm allocation. Those in the intervention arm will receive one 15mg per Kg intraoperative bolus of tranexamic acid intravenously at the time of induction of anaesthesia. With a further 15mg / kg bolus at 8hrs and 16 hours post procedure. The procedure duration is approximately 1 hour. This is the current protocol being employed by Orthopaedic surgeons and reflects the Australian Medical Handbook guidelines for dosing of tranexamic acid. The brand of tranexamic acid to be used will be Cyklokapron, currently the only product available in the Australian market.
Sponsors
Dr Andrew Fraval
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Eligible participants will be adults aged 40 or above undergoing a total hip replacement in the private practice of Mr Phong Tran.
Exclusion criteria
Exclusion criteria are: Contraindication to tranexamic acid use: - Allergies or previously known drug reaction to tranexamic acid, - Active intravascular clotting – DVT, PE or cerebral thrombosis - Predisposition to thrombosis – previous documented DVT or PE - Subarachnoid hemorrhage Rheumatoid arthritis
Outcome results
None listed