NCT05802238

Efficacy of Tranexamic Acid (TXA) in Humerus ORIF

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute) · Academic / Other
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine if administration of tranexamic acid (TXA), a clotting agent, will decrease blood loss, the need for transfusion, and reduce the likelihood of wound complications such as infection. Investigators will also see if the drug can effectively decrease operative time and length of hospitalization.

Detailed description

Single-center randomized controlled trial, parallel two-arm design allocation 1:1 exposed-control design to determine if TXA aids in prevention of blood loss in upper extremity trauma, specifically humerus fractures. Patient population includes male and female adults with no history of thromboses who suffered an isolated humeral injury. Patients will be evaluated at Allegheny General Hospital (AGH) as surgical candidates and allocated to the exposure group (receive TXA) or the control group (saline placebo). Patients randomized to treatment arm of study will have TXA administered 10 minutes prior to surgery. The control group will have saline administered 10 minutes prior to surgery. Patients will be seen in follow up at both 2 weeks and 6 weeks postoperatively, as well as followed through the electronic medical record (EMR).

Conditions

• Fracture Humerus

Interventions

Type	Name	Description
DRUG	Tranexamic acid (TXA)	1 gram of TXA in 10mg single-dose ampule (100mg/mL) administered 10 minutes prior to surgery
OTHER	Saline	control group will receive 10 mL of normal saline infused intravenously at 1 mL/min.

Timeline

• Start date: 2023-04-12
• Primary completion: 2024-11-25
• Completion: 2024-11-25
• First posted: 2023-04-06
• Last updated: 2024-12-13

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study