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Clinical Trial 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.


Clinical Trial 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). ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05802238
Study type Interventional
Source Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
Contact Pamela M. White, BSN
Phone 412-330-6044
Email Pamela.White2@ahn.org
Status Recruiting
Phase Phase 2
Start date April 12, 2023
Completion date June 30, 2030

See also
  Status Clinical Trial Phase
Recruiting NCT05096689 - Non-operative Treatment of Pediatric Lateral Humeral Condyle Fractures N/A
Recruiting NCT05773352 - Perform® Humeral System - Fracture Study (PFX)
Not yet recruiting NCT03196674 - The Effect of Controlled Feedback on the Rehabilitation of Individuals With Disability Due to Stiff Shoulder Following Trauma N/A