Safety and Efficacy of Oral Tranexamic Acid in Reducing Blood Loss and Transfusion in Femoral Neck, Intertrochanteric and Subtrochanteric Femur Fractures 100 FR 1 (2015-2)

Hip fractures are associated with significant blood loss and a subsequent need for blood transfusion. The causes of bleeding are multifactorial, increased fibrinolytic activity being one of them. The use of allogenic blood products is expensive and is associated with increased risk of hemolytic and anaphylactic reactions, post-operative infections and lengthened hospital stay. Tranexamic acid (TXA) is a simple and inexpensive pharmacological agent that inhibits fibrinolysis and reduced bleeding. It has a 44 year history of clinical use beginning with patients with symptomatic menorrhagia as well as bleeding prophylaxis in hemophiliac patients undergoing tooth extraction

Tranexamic acid (TXA) is an antifibrinolytic medication (reduces the destruction of blood clots, thus promoting the ability to stop bleeding) that is frequently used to reduce perioperative blood loss, blood transfusions and associated costs in major cardiac, vascular, obstetric, and orthopedic procedures. It has been used successfully in orthopedics to reduce perioperative blood loss, particularly in spine surgery, total knee and total hip arthroplasty (THA). Multiple recent meta-analyses have found that use of TXA in the setting of total knee arthroplasty (TKA) and THA leads to significantly less overall blood loss and lower rates of blood transfusion without increasing rates of venous thromboembolism (VTE) or other complications.

Osteoporotic hip fractures are at an increased risk than elective orthopaedic surgery patients because they are exposed to a double bleeding insult. Fractures bleed and many of these patients sustain their first hit when hematoma forms in their soft tissues leading to symptomatic anemia. Subsequently these patients sustain additional blood loss when they undergo surgery for definitive treatment of their injuries.

Trauma surgeons understand the risk of hemorrhage associated with trauma and routinely give TXA to patients who present with high energy injuries. The CRASH-2 trial was an international study which randomized 20,000 bleeding trauma patients to get TXA or matching placebo upon presentation. With 99.5% follow up, the authors noted a decreased risk of bleeding and death without ill effect.

However, there are limited data on its use in patients with hip fractures. We propose a double-blinded, randomized, controlled trial comparing perioperative administration of TXA to placebo in the setting of femur fractures. Thus our goal is to examine the safety and efficacy of TXA in reducing blood loss and red blood cell requirement for patients with intertrochanteric, subtrochanteric femur fractures at the time of hospital admission.