Role of Tranexamic acid on blood loss in hip fracture patients'
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)
Nepean Hospital (Nepean Blue Mountain Local Health District)
250 participants
Jan 5, 2017
Interventional
Conditions
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.
Eligibility
Inclusion Criteria1
- 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.
Exclusion Criteria12
- Neck of femur fractures requiring fixation by other methods e.g. by cannulated screws, dynamic hip screw or intra-medullary nail device.
- Patients presenting 48 hours from the time of injury. This includes patients transferred to Nepean hospital from other hospitals.
- 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
- Patients who are unable to provide informed consent.
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Interventions
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.
Locations(1)
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ACTRN12617000391370