Effect of Early Administration of TXA in Adult Hip Fractures

Study Overview
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Brief Summary
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This is a prospective clinical study designed to assess blood loss in intracapsular and extracapsular hip fractures undergoing operative fixation at a Level II trauma center. It is well established in the orthopedic literature that tranexamic acid (TXA) decreases blood loss and need for postoperative blood transfusion in hip fracture patients as well as total joint arthroplasty patients. A typical dosing pattern, and the dosing pattern employed at our institution, is 1 gram IV infused prior to incision followed by 1 gram IV infused at the time of wound closure.

Official Title
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Does Early Administration of Tranexamic Acid Decrease Perioperative Blood Loss in Addition to Intraoperative Tranexamic Acid for Hip Fracture Patients?

Conditions
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Postoperative Blood Loss

Intervention / Treatment
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* Drug: Tranexamic acid


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 1. All adult (18 years old or older) hip fracture patients presenting with an acute hip fracture and undergoing operative fixation Exclusion Criteria: Polytrauma patients Previous operation on the ipsilateral hip Patients with coagulopathies (Factor V Leiden, Sickle Cell Anemia, Etc.) Patients with < 6-month history of thromboembolic event (DVT/PE), Stroke, Cardiac Stents, or Myocardial Infarction (MI) History of seizure disorder Patients on birth control Pregnant Women Prisoners Active thromboembolic disease (DVT/PE, MI, Stroke)

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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Accepts Healthy Volunteers

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Early Adminstration of TXA + Intraoperative TXA<br>This group receives 1 G of TXA as soon as possible after a diagnosis of an acute hip fracture if the patient meets inclusion and exclusion criteria. The group will also receive 2 grams of TXA total intraoperatively. | Drug: Tranexamic acid<br>* TXA to be given at time of diagnosis in the emergency department (ED) in treatment group and at time of operation for both groups<br>* Other names: Lysteda;|
| Other: Intraoperative only TXA<br>This group will only receive the intraoperative TXA. | Drug: Tranexamic acid<br>* TXA to be given at time of diagnosis in the emergency department (ED) in treatment group and at time of operation for both groups<br>* Other names: Lysteda;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative Blood Transfusion | Patient receives a blood transfusion during their postoperative stay in the hospital | Up to two weeks | 
| Overall Blood Loss | Calculate the difference in postoperative blood loss between groups | Up to two weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of hospital stay | Overall length of hospital stay | Up to two weeks | 
| Postoperative Pain | Difference in overall pain scores between groups | Up to two weeks | 
| Wound complications | Acute wound complications documented after surgical intervention | Up to two weeks | 
| Acute DVT/PE | Documented deep venous thrombosis or pulmonary embolism | Up to two weeks |