Hip Fractures
Conditions
Keywords
tranexamic acid, TXA, hip fracture
Brief summary
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.
Detailed description
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.
Interventions
DRUGTranexamic acid
10 mg/kg IV TXA in the ED, repeat doses before skin incision and in PACU
DRUGNormal Saline
100 mL 0.9% normal saline in the ED, 10 mg/kg IV TXA before skin incision and in PACU
Sponsors
Community Memorial Health System
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Femoral neck, intertrochanteric, subtrochanteric femur fracture * Age \>18 * Undergoing surgical stabilization or arthroplasty by any method as determined by attending surgeon
Exclusion criteria
* Age \<18 * Concomitant fracture * Preoperative anemia needing blood transfusion before surgery * Severe comorbidity (active cancer, severe pulmonary disease, ESRD) * Allergy for tranexamic acid * History of acute thromboembolic event (Deep Vein Thrombosis, Pulmonary Embolism, Stroke, TIA) in the previous 12 months * Myocardial infarction in the previous 12 months * Renal function impairment (creatinine clearance \<30 mL/min), or kidney transplant * History of hypercoagulability (Factor V Leiden, Protein C/S deficiency)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in calculated and recorded hemoglobin | From the time of randomization until discharge from the hospital after initial admission, or 4 weeks, whichever came first. | 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. |
| Total postoperative units of red blood cell transfusion | From the time of randomization until discharge from the hospital after initial admission, or 4 weeks, whichever came first. | The number of units of RBC transfusions will be recorded and compared between treatment and placebo groups. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| VTE | Postoperative for 30 days | DVT or PE |
| Infection | Postoperative for 30 days | Superficial and deep infections |
| Readmission | Within 30 days postoperative | 30 day readmission |
| Other complications | Postoperative for 30 days | Any additional unforeseen complications |
Countries
United States
Contacts
Primary ContactMichael Allen, DO
Outcome results
None listed