Does Early Administration of Tranexamic Acid Reduce Blood Loss and Perioperative Transfusion Requirement
Condition: Hip Fractures; Intertrochanteric Fractures
MeSH terms: Fractures, Bone; Hip Fractures
Intervention: Tranexamic Acid (TXA); Placebo
Intervention description: 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
Intervention MeSH terms: Tranexamic Acid
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Subjects will be randomized into one of two study groups: TXA administration (treatment) or placebo (control). In order to ensure balance on the subject demographics between the two study groups, the subjects will be stratified on gender, age group (<75 vs. ≥75) and body mass index (<30 vs. ≥30). Within each stratum, subjects will be assigned to either the treatment group or control group using an electronic dynamic allocation program housed in a computer application developed by personnel in the Division of Biomedical Statistics and Informatics.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description: Using dynamic allocation will ensure that the study subjects will remain balanced on the stratification factors and the treatment group assignment throughout the entire subject accrual phase. This system will be utilized by Central pharmacy personnel to generate the treatment group assignments. Medications will then be delivered from the Central Pharmacy to the emergency department in packaging that does not delineate whether it contains placebo or tranexamic acid. Thus, the patient, treating surgeon, emergency department physician, residents, hospitalist group, anesthesiologist, and data collectors will remain blinded to the treatment assignment.
Enrollment: 128.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

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.
    

Eligibility criteria:

        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