Safety and Efficacy of Oral TXA in Reducing Blood Loss and Transfusion in Hip Fractures

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.

Inclusion Criteria:

Patients presenting with femoral neck, intertrochanteric and subtrochanteric femur
fractures Patients age 18 and older Low energy injury

Exclusion Criteria:

Pregnant or breast-feeding women Allergy to tranexamic acid Acquired disturbances of color
vision Thrombophilia Antithrombin deficiency Factor V Leiden Antiphospholipid Syndrome
Protein C and S deficiency History of heparin induced thrombocytopenia Sickle cell anemia
Myeloproliferative disorders International Normalized Ratio (INR) > 1.4 Partial
Thromboplastin Time (PTT) > 1.4 times normal A history of arterial or venous
thromboembolism Cerebral Vascular Accident Deep Vein Thrombosis Pulmonary Embolism
Subarachnoid hemorrhage Active intravascular clotting Participation in another clinical
trial