Topical Tranexamic Acid (TXA) in Hip Fractures

Study Overview
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Brief Summary
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Mechanisms by which to reduce exposure to allogeneic blood are of financial and clinical benefit in the hip fracture population. Tranexamic acid (TXA) is an inexpensive medication with low complication risk. Its use in the hip fracture population is unproven. The purpose of this study is to evaluate the efficacy and safety of topical tranexamic acid in reduction of peri-operative blood loss in hip fracture surgery.

Detailed Description
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The results of this study may dramatically alter the manner in which surgeons manage hip fracture patients in Canada. The use of topical TXA in operatively-treated hip fracture patients has the potential to reduce perioperative blood loss and consequently reduce exposure to allogeneic blood transfusion. This will positively influence post-operative morbidity and mortality, while at the same time substantially reduce hospital length of stay and overall health care costs. The proposed study is felt to have minimal risk, and is a relatively inexpensive study. Update: An interim analysis was completed in January 2018. The Data Safety Monitoring Committee reviewed the results and recommend the trial continue as planned. The final data analysis is in process. The abstract will be uploaded upon completion.

Official Title
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Topical Tranexamic Acid (TXA) in Hip Fractures, A Double-Blind, Randomized Controlled Trial

Conditions
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Hip Fracture, Anemia

Intervention / Treatment
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* Drug: Tranexamic Acid
* Other: Saline Wash


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All of the following criteria must be met to be eligible: 18 years of age or older Diagnosis of hip fracture (Intracapsular, Intratrochanteric or Subtrochanteric) requiring surgical repair Patient/surrogate decision maker provide signed informed consent Exclusion Criteria: Participants cannot be included in this study if any of the following criteria apply: Patient has documented renal failure with glomerular filtration rate of <30ml/min/1.73m2 Documented allergy to tranexamic acid Current use of hormone replacement therapy Acquired disturbances of colour vision Refusal of blood products Pre-operative use of anticoagulant therapy (Coumadin, heparin < 5 days of surgery, fibrinolytic disorders requiring intraoperative anti-fibrinolytic treatment) Coagulopathy (pre-operative platelet count <150,000/mm3, International Normalized Ratio (INR) >1.4, prolonged Partial Thromboplastin Time (PTT) >1.4x normal) Hematuria Acute coronary syndrome within 6 weeks of fracture Any history of venous thromboembolism Any intraoperative surgical/medical/anesthetic complications i.e.: myocardial infarction or neurovascular injury occurring prior to application of the tranexamic acid Pregnant or lactating Any major medical or psychiatric disorder that in the opinion of the investigator, might prevent the subject from completely participating in the study or interfere with the interpretation of the study results Unable/unwilling to provide informed consent

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tranexamic Acid Wash<br>Participants in the experimental arm will receive a wash of tranexamic acid topically at the site of surgery. | Drug: Tranexamic Acid<br> <br> |
| Placebo Comparator: Saline Wash<br>Participants in the control arm will receive a wash of saline topically at the site of surgery. | Other: Saline Wash<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in hemoglobin | change in hemoglobin levels day 1 and 3 post-op compared to pre-op values and need for allogenic blood transfusion up to 3 days post-op | 1 day and 3 days post-surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All-cause mortality |  | 30 days post-surgery | 
| Reduced risk of thrombotic event | Measure incidence of venous thromboembolism (symptomatic ultrasound proven deep vein thrombosis or pulmonary embolism diagnosed by a ventilation-perfusion scan or computed tomography angiogram) | 30 days post-surgery | 
| Reduced peri-operative complications | (post-operative surgical site infection, acute coronary syndrome, cerebrovascular event) | 30 days post-surgery |