Evaluation of TXA Prior to Surgery in the Geriatric Hip Fracture Population

Study Overview
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Brief Summary
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The overall design of the study is a prospective, double-blinded, randomized study in the geriatric hip fracture population comparing those who receive intravenous tranexamic acid prior to incision to those who receive a placebo.

Detailed Description
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A significant portion of the geriatric hip fracture population have comorbidities including chronic kidney disease, congestive heart failure, ischemic heart disease, stroke, etc. These patients may be anemic prior to the surgery, and are at increased risk for further blood loss as a result of the fracture and surgical operation. However, intra-operative or post-operative blood transfusions also increase the risk of renal and cardiac complications in this population. Tranexamic acid (TXA) is an anti-fibrinolytic medication that has transformed total joint replacement management regarding blood loss prevention. Geriatric patients requiring emergent hip fracture repair may significantly benefit from routine administration of TXA prior to the procedure to decrease the risk of blood loss. Thus, treatment may further reduce the percentage of patients who experience blood transfusions and complications associated with transfusions. The investigators will examine if administration of TXA prior to incision in the geriatric hip fracture patient population decreases the risk of intra-operative or post-operative blood transfusions compared to placebo.

Official Title
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Evaluation of Tranexamic Acid Prior to Surgery in the Geriatric Hip Fracture Population for the Reduction of Post-Operative Blood Transfusion

Conditions
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Hip Fractures

Intervention / Treatment
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* Drug: Tranexamic Acid Injectable Solution
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Provision of written informed consent Age > or = to 65 years Hip fracture location within the femoral neck, intertrochanteric, and subtrochanteric regions Indication for one of the following surgical interventions: hemiarthroplasty, total hip replacement, sliding plate and screw fixation, or intramedullary fixation Exclusion Criteria: Indication for closed reduction or percutaneous screw Allergy to TXA Cerebrovascular accident/stroke, active coronary disease/myocardial infarction, or deep vein thrombosis/pulmonary emboli within one (1) month of the fracture Presence of hypercoaguable disorder, including cancer (active disease), elevated blood homocysteine levels, antiphospholipid antibody syndrome and inherited protein deficiencies (antithrombin III, factor V Leiden, protein S & C deficiencies, prothrombin gene mutation)

Ages Eligible for Study
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Minimum Age: 65 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
Interventional Model Description: A prospective, double-blinded, randomized study in the geriatric hip fracture population comparing those who receive intravenous tranexamic acid prior to incision to those who receive a placebo.
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Intervention<br>100 cc normal saline with 1g of tranexamic acid in solution | Drug: Tranexamic Acid Injectable Solution<br>* 100 cc normal saline mixed with 1g of tranexamic acid in solution<br>* Other names: Cyklokapron;|
| Placebo Comparator: Placebo<br>100 cc normal saline | Other: Placebo<br>* 100 cc normal saline<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood Transfusions | To compare the percentage of patients that receive acute post-operative transfusions in the group administered intravenous tranexamic acid compared to the group administered placebo. | 3 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complication Rate | Determine if participants randomized to TXA experienced increased risk of complications compared to placebo. Complications include number of deep vein thrombosis events, pulmonary emboli events, myocardial infarction events, and cerebral vascular events within 12 weeks post hip fracture surgery. | 3 Months | 
| Hospital Readmission | Determine differences between the groups in 30 day readmission rates. | 30 Days | 
| Mortality Rate | Death within 90 days post hip surgery | 90 Days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Blood, Transfusion, Hip, Fracture, Surgery, Replacement, Trauma