None listed
Conditions
Brief summary
According to the annual report from national joint replacement registry, around 32000 primary total hip replacements (THR) have been performed in 2017 in Australia. Reported prevalence of blood transfusion in THR is around 24%. Blood transfusions are associated with infectious risk and complications such as acute lung injury, and acute or delayed immune responses. Tranexamic acid (TXA) has been widely used for its anti- fibrinolytic effect in major joint replacement surgery. It has been shown to prevent excess bleeding and reduce the risk of blood transfusion following lower limb joint replacements. Current dosing of TXA for joint replacement surgery is not based on rigorous scientific evidence and dosing based on bleeding endpoints may be sub-optimal. In this study, we propose investigating the use of biomarkers to describe the extent of fibrinolysis as dosing endpoints for the physiological effect of TXA. From this, we will provide recommendations for effective dosing regimens of TXA in patients undergoing THR.
Interventions
Intravenous tranexamic acid 15 mg/kg is administered as a routine practice during hip replacement surgery.24 adult patients 18 years and over, undergoing elective unilateral primary hip replacements and 10 patients undergoing elective revision hip replacements under general anaesthesia, and receiving intravenous tranexamic acid 15 mg/kg at The Prince Charles Hospital will be enrolled. Additional intravenous tranexamic acid may be administered according to the discretion of surgeon. No topical t
Intravenous tranexamic acid 15 mg/kg is administered as a routine practice during hip replacement surgery.24 adult patients 18 years and over, undergoing elective unilateral primary hip replacements and 10 patients undergoing elective revision hip replacements under general anaesthesia, and receiving intravenous tranexamic acid 15 mg/kg at The Prince Charles Hospital will be enrolled. Additional intravenous tranexamic acid may be administered according to the discretion of surgeon. No topical tranexamic acid will be administered. Blood samples will be collected at the time points: baseline, 5 minutes after tranexamic acid, skin incision, skin closure, 3 hours, 8 hours and 24 hours after tranexamic acid, for assessing tranexamic acid levels and to measure biomarkers to describe changes to the extent of fibrinolysis during surgery. This will involve additional blood samples at these time points. If there is existing cannula, blood samples will be drawn from them. Participants will be observed from induction of anaesthesia until 24 hours following surgery. A population pharmacokinetic-pharmacodynamic model will be developed on the concentration-time data generated and fibrinolysis biomarkers, using the software PMetrics, from which dosing simulations will be performed and recommendations for effective dosing of tranexamic acid will be obtained.
Sponsors
Usha Gurunathan
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patient undergoing unilateral total hip replacment and receiving tranexamic acid; Age greater than or equal to 18 years old; Written informed consent obtained from the patient
Exclusion criteria
Consent not obtained; Patients in whom tranexamic acid would be contraindicated such as cerebrovascular or coronary event in the past 12 months, end stage renal disease, those at a very high risk of thromboembolism, or documented allergy etc; Patients with communication barrier due to language issues; Urgent arthroplasty or hemiarthroplasty due to hip fractures; Bilateral THR
Outcome results
None listed