Does Early Administration of Tranexamic Acid Reduce Blood Loss and Perioperative Transfusion Requirement

Phase 2

Completed

Brief Summary: 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.

Detailed Description: 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.

Recruitment & Eligibility

Inclusion Criteria

AO/OTA fracture classification 31A
Surgically treated with sliding hip screw or cephalomedullary nail (short or long)
Low energy, isolated injury

Exclusion Criteria

Intracapsular hip fractures: AO/OTA fracture classification 31B-C
Polytrauma patients
Creatinine clearance less than 30 mL/min
History of unprovoked VTE and/or recurrent VTE
Known history of Factor V Leiden, protein C/S deficiency, prothrombin gene mutation, anti-thrombin deficiency, anti-phospholipid antibody syndrome, lupus anticoagulant
Pregnancy or breastfeeding (pregnancy tests will be performed on all patients of child-bearing potential)
History of CVA, MI, or VTE within the previous 30 days
Coronary stent placement within the previous 6 months
Disseminated intravascular coagulation
Intracranial hemorrhage

Arm && Interventions

Group	Intervention	Description
Control Arm	Placebo	Subjects will be treated with a placebo in the Emergency Department
Tranexamic Acid Arm (TXA)	Tranexamic Acid (TXA)	Subjects will be treated with early administration of TXA in the Emergency Department

Primary Outcome Measures

Name	Time	Method
Number of Subjects Transfused at Least 1 Unit of Packed Red Blood Cells	Length of hospitalization (approximately 3 to 5 days)	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.

Secondary Outcome Measures

Name	Time	Method
All-cause Mortality	At 6 months after surgery	Number of subject deaths
(Myocardial Infarction) MI Diagnosed	Within 6 months of surgery	Number of subjects diagnosed with a myocardial infarction
Number of Subjects to Experience Symptomatic Venous Thromboembolism (VTE)	Within 6 months of surgery	Number of subjects to experience symptomatic Venous Thromboembolism (VTE)
Cerebrovascular Accident (CVA) Diagnosed	Within 6 months of surgery	Number of subjects diagnosed with a cerebrovascular accident
Number of Units of Packed Red Blood Cells Transfused	Length of hospitalization (approximately 3 to 5 days)	Number of units of packed red blood cells transfused per patient
Calculated Blood Loss	Length of hospitalization (approximately 3 to 5 days)	Total blood loss per patient measured in milliliters (mL)
Wound Complications	Within 6 months of surgery	Number of subjects diagnosed with a wound complication