Prospective Study: TXA, Anticoagulant, Orthopaedic Trauma

Arbi Nazarian, MD

Status and phase: Not yet enrolling; Phase 4

Conditions: Patients Undergoing Operative Fixation of Long Bone Fractures Within the Community Medical Centers System

Treatments: Drug: Tranexamic Acid (TXA)

Study type: Interventional

Funder types: Other

Identifiers

NCT07116395

Nazarian_TXA_Prospective2025

Details and patient eligibility

About

Tranexamic acid, an anti-fibrinolytic agent, is commonly given after induction of general anesthesia in patients undergoing hip and knee arthroplasty. This medication has been associated with decreased blood loss during these procedures, decreased rate of blood transfusion, decreased hospital costs, and no increased risk of thrombotic complication. Given the safety and efficacy of this medication in one subspeciality of orthopedics, it is warranted to investigate the use of it in another subspeciality where blood loss is also of concern. It is also of the utmost importance to identify medications that can safely be given to our population to not only improve patient outcomes but also decrease patient costs in the setting of significant disparities. The application of these findings to orthopedic trauma is not something that has been largely studied or appears in the literature. We hope to fill this gap of knowledge to allow for the application of a safe and beneficial medication to a much larger subset of patients than that that is already receiving the medication routinely. The use of TXA in orthopedic patients who are on anticoagulation versus those who are not is also not something that has been previously studied and another knowledge gap that we hope to fill.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients undergoing operative fixation of long bone fractures; Included conditions include femoral neck fractures, intertrochanteric femur fractures, femoral shaft fractures, distal femur fractures, and tibial shaft fractures that undergo surgical management

Exclusion criteria

• Exclusion criteria for this study will be patients under 18 and prisoners

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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200 participants in 2 patient groups

Yes TXA Administered

Experimental group

Treatment:

Drug: Tranexamic Acid (TXA)

No TXA Administered

No Intervention group