Effect of Intravenous Tranexamic Acid on Reduction of Blood Losses in Hip Fracture Patients

Candidates for the study will be consecutive patients with a diagnosis of hip fractures treated at our center. All patients with hip fracture meeting inclusion criteria will be recruited for enrollment into the study. Informed consent will be obtained from the patient prior to randomization.

At that time, each patient will be randomized into one of two groups by a independent staff using computer generated randomization and allocation concealment. The two patient groups will include:

• Study group: 1g of intravenous tranexamic acid at the time of surgical incision.
• Control group: placebo injection (saline solution) 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.

Patients will be treated surgically with a long trochanteric femoral nail (TFN) or hemiarthroplasty.

Blood transfusion criteria will remain consistent with hospital standards (Hb<8 g/dL or >9 g/dL if symptomatic anemia). Total number of blood transfusions received will be documented upon patient discharge.

Deep vein thrombosis (DVT) prophylaxis will remain consistent with hospital standards (subcutaneous heparin from admission until 12 hours prior to surgery and beginning 6 hours after surgery). After discharge, .....

Patients will be followed at regular intervals (1mo, 3mo, and at least 6mo) and at each time point the patient will be asked to report any adverse events (DVT, PT, Stroke, myocardial infarction, infection, hospitalization). 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.

Inclusion criteria

• consecutive patients with a diagnosis of hip fractures treated at our hospital by any surgical procedureExclusion Criteria:
• Age over 60 years

Exclusion criteria

• ASA IV
• Concomitant fracture
• Refusal to receive blood products
• Preoperative anemia needing blood transfusion before surgery
• Severe comorbidity (cancer, severe pulmonary disease)
• Allergy for tranexamic acid.
• History of acute thromboembolic event (Deep Vein Thrombosis, Pulmonary Embolism, Stroke)
• Coagulopathy (INR > 1.4)
• Myocardial infarction in the previous 12 months
• Coronary stents
• Renal function impairment (serum creatinine > 2 mg/dL or creatinine clearance <30 mL/min),) or kidney transplant
• Platelet antiaggregant treatment in the week before surgery.
• Severe hepatic dysfunction (AST/ALT >60)
• History of hypercoagulability
• Acquired disturbances of color vision.
• Occurrence intraoperative surgical/medical/anesthetic complications