Blood Loss After Early TXA in Hip Fractures.

Status Recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04488367
Study type	Interventional
Source	Community Memorial Health System
Contact	Michael Allen, DO
Phone	805-948-5100
Email	mallen@cmhshealth.org
Status	Recruiting
Phase	Early Phase 1
Start date	July 6, 2020
Completion date	July 2023

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