Our present study aims to initiate TXA administration immediately upon diagnosis of hip fracture in the Emergency Department. This will be a single blind randomized controlled trial comparing early administration of TXA in the ED in addition to perioperative dosing versus the standard perioperative administration only. The study population will include patients who have sustained a femoral neck, intertrochanteric, or subtrochanteric femur fracture and are undergoing surgical internal fixation or arthroplasty. We will prospectively compare the need for blood transfusion, total and hidden blood loss, postoperative complications, length of stay and readmission within 30 days.
Consent will be obtained for study enrollment from the patient or legal decision maker. The patient will then be randomized and stratified based on the fracture type, fixation method anticipated, and presence of anticoagulation. Treatment drug and saline placebo will be blinded from the patient. Treatment arm patients will receive a dose of 10 mg/kg of TXA IV as soon as possible in the ED. They will then receive repeat doses prior to skin incision and again after the end of surgery. Control group will receive a placebo dose of normal saline in the ED and then the standard 10 mg/kg TXA doses prior to surgery and again after the end of surgery. The perioperative doses will not be blinded.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
120
10 mg/kg IV TXA in the ED, repeat doses before skin incision and in PACU
100 mL 0.9% normal saline in the ED, 10 mg/kg IV TXA before skin incision and in PACU
Community Memorial Hospital
Ventura, California, United States
RECRUITINGChange in calculated and recorded hemoglobin
Change in hemoglobin (blood loss) will be assessed based on preoperative blood draw and blood draws post op and on each inpatient day during hospitalization.
Time frame: From the time of randomization until discharge from the hospital after initial admission, or 4 weeks, whichever came first.
Total postoperative units of red blood cell transfusion
The number of units of RBC transfusions will be recorded and compared between treatment and placebo groups.
Time frame: From the time of randomization until discharge from the hospital after initial admission, or 4 weeks, whichever came first.
VTE
DVT or PE
Time frame: Postoperative for 30 days
Infection
Superficial and deep infections
Time frame: Postoperative for 30 days
Readmission
30 day readmission
Time frame: Within 30 days postoperative
Other complications
Any additional unforeseen complications
Time frame: Postoperative for 30 days
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