Blood Loss After Early TXA in Hip Fractures.

• Status: Recruiting
• Trial end date: 2021-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Community Memorial Health System
• Treatments: Tranexamic Acid

Criteria

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)