Topical Application of Tranexamic Acid and Postoperative Blood Loss in Femoral Neck Fractures

Study Overview
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Brief Summary
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Tranexamic acid (TA) is a synthetic antifibrinolytic agent. It prevents degradation of fibrin and delays the breakdown of hemostatic clots. It has been demonstrated in multiple studies and meta analyses to decrease blood loss in elective hip and knee arthroplasty. However, concerns about the prothrombotic side effects of systemic administration of TA has hindered the widespread adoption of this medication in orthopaedic patients due to their high risk for thrombotic complications such as deep venous thrombosis and pulmonary embolism Topical application of tranexamic acid has been proposed as a way to mitigate the potential prothrombotic effects of TA. Topical application of TA has been demonstrated to be beneficial in oral and cardiac surgery. Plasma levels of TA have been found to be minimal following topical application, minimizing its potential systemic thromboembolic side effects. TA has been used topically in total knee arthroplasty, with significant reductions in blood loss and no increase in thromboembolic complications8,10. Data on the use of TA in hip fracture surgery is limited, and there are no studies examining topical use of TA in hip fracture surgery.

Detailed Description
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Our study question is: Does topical tranexamic acid decrease blood loss following hemiarthroplasty of the hip for femoral neck fractures? The type of information collected by the research assistant will consist of estimated blood loss during surgery, length of stay in hospital, any wound infections as well as any thromboembolic side effects (blood clots in legs and/or heart) that may occur. The number of units of red blood cells transfused will be recorded up to and including postoperative day 8. Preoperative hemoglobin and lowest postoperative hemoglobin levels up to and including post-op day 8 will also be collected as well as any use of ambulatory aids will be recorded on presentation to hospital, discharge and 6 weeks post operatively.

Official Title
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Phase III Examining the Topical Application of Tranexamic Acid and Postoperative Blood Loss in Femoral Neck Fractures: a Randomized Control Trial.

Conditions
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Femoral Neck Fracture

Intervention / Treatment
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* Drug: Tranexamic Acid
* Other: placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: hip fracture patients aged 65 and older. Exclusion Criteria: bilateral femoral neck fracture patient and/or one that is not suited to a hemiarthroplasty repair.

Ages Eligible for Study
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Minimum Age: 65 Years
Maximum Age: 95 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: tranexamic acid<br>3000mg/mL tranexamic acid in saline applied directly to the wound at the end of the surgical procedure. | Drug: Tranexamic Acid<br>* drug and placebo applied topically at end of surgery at hip site.<br>* Other names: Cyklokapron;|
| Placebo Comparator: saline<br>3000mg/mL saline applied directly to the wound at the end of the surgical procedure | Other: placebo<br>* applied topically to surgical site in OR.<br>* Other names: saline solution;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood loss |  | postop 0-8 days. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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fracture, hip, tranexamic acid, topical