The Effect of Tranexamic Acid on Blood Loss and Transfusion Requirements Following Open Femur Fracture Surgery

Study Overview
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Brief Summary
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The purpose of this study is to determine the effect of tranexamic acid (TXA) on blood loss and transfusion requirements in patients with femur fractures requiring open surgical approaches.

Official Title
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The Effect of Tranexamic Acid on Blood Loss and Transfusion Requirements Following Open Femur Fracture Surgery

Conditions
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Blood Loss Following Open Femur Fracture Surgery

Intervention / Treatment
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* Drug: Tranexamic acid (TXA)
* Drug: Normal saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients admitted to Memorial Hermann Medical Center with acute femur fractures that require open surgical approaches for fracture reduction and implant application, including patients with subtrochanteric, high-energy intertrochanteric, periprosthetic, and intra-articular distal femur fractures. Exclusion Criteria: Preoperative use of any anticoagulant History of deep venous thrombosis or pulmonary embolus Allergy to TXA Hepatic dysfunction (AST/ALT > 60) Renal dysfunction (Cr > 1.5 or GFR < 30) History of cerebrovascular accident in the past 12 months Active coronary artery disease (event in the past 12 months) Presence of drug-eluting stent Color blindness Presence of an additional acute injury that could contribute to blood transfusion requirements

Ages Eligible for Study
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Minimum Age: 18 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tranexamic acid (TXA)<br>Following induction of anesthesia and prior to surgical incision, patients will receive 1 gram of intravenous TXA mixed in 100cc of normal saline. | Drug: Tranexamic acid (TXA)<br>* Following induction of anesthesia and prior to surgical incision, patients will receive 1 gram of intravenous TXA mixed in 100cc of normal saline.<br>|
| Placebo Comparator: Normal saline<br>Following induction of anesthesia and prior to surgical incision, patients will receive 100cc of normal saline. | Drug: Normal saline<br>* Following induction of anesthesia and prior to surgical incision, patients will receive 100cc of normal saline.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Transfusion requirements as assessed by number of packed red blood cell units received |  | from the time of surgery to hospital discharge (about 3-5 days) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Surgical blood loss as assessed by change in red blood cell volume | Blood loss will be determined using the following calculations: [Patient's Blood Volume (PBV) = (k1 x Height^3 (m)) + (k2 x Weight (kg)) + k3] (- k1 = 0.3669, k2 = 0.03219, and k3 = 0.6041 for men) (- k1 = 0.3561, k2=0.03308, and k3 = 0.1833 for women) Multiplying the PBV by the hematocrit (Hct) gives the red blood cell (RBC) volume. As such, a change in the RBC volume can be calculated from a change in the Hct level as follows. PACU is post-anesthesia care unit: [Operative RBC volume loss = PBV x (Day of surgery Hct - PACU Hct)] If a patient requires an intraoperative transfusion, the calculation will be adjusted as follows: Operative RBC volume loss = [ [PBV x (Day of surgery Hct - PACU Hct)] +)] + (No. of Units Transfused x 0.285) / (Day of surgery Hct - Post-op Hct) / 2) ] | baseline, while in PACU (which is about 4-6 hours after surgery) | 
| Surgical blood loss as assessed by an intraoperative cell salvage machine | The intraoperative cell salvage machine allows for a precise estimation of surgical blood loss. | at the time of surgery | 
| Length of hospital stay |  | from the time of hospital admission to the time of hospital discharge (about 5 days) | 
| Number of participants with complications | Complications include infection, venous thromboembolic event, and mortality. | 6 weeks after surgery |