Does Tranexamic Acid Reduce the Need for Blood Transfusions in Patients Undergoing Hip Fracture Surgery?

Study Overview
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Brief Summary
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Does tranexamic acid improve the perioperative care of those patients treated surgically for hip fracture by decreasing the proportion of patients requiring transfusion and decreasing total perioperative bleeding.

Detailed Description
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Antifibrinolytic medications such as tranexamic acid, aprotinin, and aminocaproic acid have proven to be useful in decreasing blood loss and the proportion of patients who require transfusion after a number of surgical procedures. In orthopedic surgery, tranexamic acid (TXA) is the best studied of these medications and a recent Cochrane Database review determined that tranexamic acid was effective in decreasing perioperative bleeding and post-operative transfusion after elective hip replacement and knee replacement surgery. At Mayo Clinic Rochester, the routine administration of tranexamic acid has evolved over the past decade to become part of the typical protocol for more than 3,000 elective hip and knee replacement procedures each year. Recent administrative data provides fairly compelling evidence of the efficacy of tranexamic acid in decreasing transfusion at the Mayo Clinic Rochester practice with 2010 data showing 2% and 7% prevalence of transfusion in patients treated with tranexamic acid versus 18% and 33% prevalence in those knee and hip replacement patients, respectively, who were not treated with tranexamic acid. A recent analysis of the Mayo Clinic Rochester orthopedic practice showed that patients treated for hip fracture remain at substantial risk of perioperative transfusion (30% prevalence) after operative management. This raises the question as to whether tranexamic acid could improve the perioperative care of those patients treated surgically for hip fracture by decreasing the proportion of patients requiring transfusion and decreasing total perioperative bleeding.

Official Title
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Is Tranexamic Acid Effective in Limiting Transfusion After Hip Replacement for Femoral Neck Fracture: A Randomized Controlled Trial

Conditions
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Hip Fracture

Intervention / Treatment
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* Drug: tranexamic acid
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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Inclusion criteria AO/OTA (Orthopedic Trauma Association) fracture classification 31B Surgically treated with either hemiarthroplasty or total hip arthroplasty Acute fracture treated within 72 hours of injury Low energy isolated injury Age greater than 18 years old Exclusion Criteria Transfusion received during admission, prior to surgery Creatinine clearance less than 30 mL/min History of unprovoked Venous Thromboembolism (VTE) and/or recurrent VTE Known history of Factor V Leiden, protein C/S deficiency, prothrombin gene mutation, anti-thrombin deficiency, anti-phospholipid antibody syndrome, lupus anticoagulant Pregnancy or breastfeeding (pregnancy tests will be performed on all patients of child-bearing potential) History of cerebrovascular accident (CVA), Myocardial infarction (MI), or VTE within the previous 30 days Coronary stent placement within the previous 6 months Disseminated intravascular coagulation Subarachnoid hemorrhage

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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: placebo<br>Normal saline will be administered intravenously in two doses of 15 mg/kg each administered over a period of ten minutes, one dose just prior to incision and the second at initiation of wound closure. | Drug: placebo<br>* A similar dose of 0.9% sodium chloride (NaCL) will be administered intravenously in two doses over a ten minute period, one dose at incision and the other at initiation of wound closure.<br>|
| Active Comparator: tranexamic acid<br>Tranexamic acid will be administered intravenously in two doses of 15 mg/kg each administered over a period of ten minutes, one dose just prior to incision and the second at initiation of wound closure. | Drug: tranexamic acid<br>* Tranexamic acid will be administered intravenously in two doses of 15 mg/kg. Each dose will be administered over a period of ten minutes, one dose just prior to incision and the second at initiation of wound closure.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Who Received a Hospitalization Transfusion | Proportion of patients transfused at least 1 unit of packed red blood cells during hospital admission | 5 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Number of Units Transfused | Mean number of units transfused per patient | 5 days | 
| Calculated Blood Loss | Calculated blood loss | 5 days | 
| Number of Participants With Venous Thromboembolism (VTE) Diagnosis | Incidence of symptomatic VTE diagnosed within 6 months of surgery | Within 6 months of surgery | 
| Number of Participants With Wound Complications | Wound complications diagnosed within 6 months of surgery | Within 6 months of surgery | 
| Number of Participants With Myocardial Infarction (MI) Diagnosis | MI diagnosed within 6 months of surgery | Within 6 months of surgery | 
| Number of Participants With Cerebrovascular Accident (CVA) Diagnosis | CVA diagnosed within 6 months of surgery | Within 6 months of surgery | 
| Number of Participants Who Died | All-cause mortality at 6 months | 6 months after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Arbeitsgemeinschaft für Osteosynthesefragen (AO) fracture, Orthopaedic Trauma Association (OTA) fracture