Blood Loss After Early TXA in Hip Fractures.

Community Memorial Health System

Status and phase: Enrolling; Early Phase 1

Conditions: Hip Fractures

Treatments: Drug: Tranexamic acid; Drug: Normal Saline

Study type: Interventional

Funder types: Other

Identifiers

NCT04488367

TXARCT1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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120 participants in 2 patient groups

Early TXA

Experimental group

Description:

Experimental group will receive 10 mg/kg IV TXA while in the Emergency Department, and repeat preoperative and postoperative doses.

Treatment:

Drug: Tranexamic acid

Control

Other group

Description:

Control group will receive 100 mL 0.9% normal saline in the Emergency Department, and 10 mg/kg IV TXA before skin incision and again in post anesthesia care unit.

Treatment:

Drug: Normal Saline