Intertrochanteric hip fractures typically result in blood loss from the fracture and require surgery that can cause further blood loss. This study is being done to look at a medication called tranexamic acid which may reduce blood loss and the need for blood transfusions associated with surgery.
The use of TXA in orthopedic trauma patients is an area of current research interest. A 2010 prospective randomized, controlled trial of perioperative TXA demonstrated reduction in transfusion requirements for intertrochanteric hip fractures treated with short, cephalomedullary nails. This was clinically, though not statistically, significant. Investigators recently conducted a randomized, controlled trial at this institution to evaluated the use of TXA in patients with femoral neck fractures treated with hemiarthroplasty or total hip arthroplasty and found clinically, albeit not statistically, significant reduction in transfusion requirement (accepted for publication). Perhaps tempering the effect seen with perioperative administration of TXA is the blood loss that occurs prior to surgery, the so-called "hidden" blood loss that can be as substantial as 1/3 of total blood loss from a hip fracture. This raises the question whether administration of tranexamic acid at the time of initial presentation after fracture could improve the perioperative care of these patients by decreasing the proportion of patients requiring transfusion and decreasing total blood loss.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
128
Intravenously via bolus dose of 1g over ten minutes and an additional 1g over the subsequent 8 hours
Looks exactly like the study drug, but it contains no active ingredient
Mayo Clinic
Rochester, Minnesota, United States
Number of Subjects Transfused at Least 1 Unit of Packed Red Blood Cells
Transfusion will be considered for all patients with hemoglobin values of less than 8 g/dL with persistent symptoms or history of significant cardiac disease that may render the patient less able to compensate for significant anemia. Blood transfusion will be considered in all patients with hemoglobin less than 7 g/dL, regardless of symptoms.
Time frame: Length of hospitalization (approximately 3 to 5 days)
Number of Units of Packed Red Blood Cells Transfused
Number of units of packed red blood cells transfused per patient
Time frame: Length of hospitalization (approximately 3 to 5 days)
Calculated Blood Loss
Total blood loss per patient measured in milliliters (mL)
Time frame: Length of hospitalization (approximately 3 to 5 days)
Number of Subjects to Experience Symptomatic Venous Thromboembolism (VTE)
Number of subjects to experience symptomatic Venous Thromboembolism (VTE)
Time frame: Within 6 months of surgery
Wound Complications
Number of subjects diagnosed with a wound complication
Time frame: Within 6 months of surgery
(Myocardial Infarction) MI Diagnosed
Number of subjects diagnosed with a myocardial infarction
Time frame: Within 6 months of surgery
Cerebrovascular Accident (CVA) Diagnosed
Number of subjects diagnosed with a cerebrovascular accident
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Time frame: Within 6 months of surgery
All-cause Mortality
Number of subject deaths
Time frame: At 6 months after surgery