The Effect of Tranexamic Acid on Transfusion Rates in Intertrochanteric Hip Fractures

All patients meeting specified criteria will be recruited for enrollment into the study.
Informed consent will be obtained from the patient or health care proxy upon diagnosis of
intertrochanteric hip fracture by the on-call orthopedic resident or research coordinator.
At that time, each patient will be randomized into one of two cohorts (Figure 1) by the
hospital's Investigational Pharmacy using computer generated randomization and allocation
concealment. The Investigational Pharmacy will also be responsible for the storage,
preparation and distribution of both the tranexamic acid and the placebo injections. The two
patient groups will include:

1. 1g of intra-venous tranexamic acid upon presentation to the emergency department and
again at the time of surgical incision.

2. Placebo injections upon presentation to the emergency department and again at the time
of surgical incision.

Both patients and the treating surgeons will be blinded with regard to placebo vs. treatment
until completion of the study. All patients will be treated surgically with a long
trochanteric femoral nail (TFN). Blood transfusion criteria will remain consistent with
hospital standards (Hb<8 g/dL or symptomatic anemia) as determined by an independent,
blinded medical team who will follow the patient throughout the hospital stay. Total number
of blood transfusions received will be documented upon patient discharge.

All patients will be permitted to weight bear as tolerated post-operatively and deep vein
thrombosis (DVT) prophylaxis will be standardized: subcutaneous heparin, 5000 units every 8
hours beginning upon admission until 12 hours prior to surgery and beginning 6 hours after
surgery for a total of 6 weeks. Calf mechanical compression devices will also be utilized
during the inpatient stay and will remain on at all times with the exception of physical
therapy sessions. Diagnostic studies to assess for thromboembolic events (i.e. DVT,
pulmonary embolism (PE), and stroke) will be ordered only if the patient develops clinical
signs or symptoms that justify their use. Patients will be followed at regular intervals
(6wk, 3mo, 6mo, 1 year) and at each time point the patient will be asked to report any
adverse events (DVT, PT, Stroke, myocardial infarction, infection, hospitalization) that
have occurred since their last visit. In cases where patients are unable to accurately
report their medical history, care providers will be questioned and records will be obtained
from care facilities if necessary. An attempt will be made to contact any patient who is
lost to follow-up via telephone and U.S. Mail.

Safety of the study will be monitored by an independent Data Safety Monitoring Board at 6
month intervals and the study will be discontinued at their discretion based on the number
of adverse events.

Inclusion Criteria:

- Intertrochanteric Hip Fracture

- Age >18

Exclusion Criteria:

- Preoperative use of anticoagulant (Clopidogrel, Warfarin, Enoxaparin, Fondaparinux,
Rivaroxaban

- Allergy to Tranexamic Acid

- History of intracranial hemorrhage or significant GI or retroperitoneal bleed
requiring hospitalization

- History of thromboembolic event (Stroke, Deep Vein Thrombosis, Pulmonary Embolism)

- History of cirrhosis or evidence of hepatic (AST/ALT >60) or renal dysfunction (Cr
>1.5 or GFR <30)

- Coronary stents or prior diagnosis of CAD

- Color blindness