NCT03923959

Evaluation of TXA Prior to Surgery in the Geriatric Hip Fracture Population

Evaluation of Tranexamic Acid Prior to Surgery in the Geriatric Hip Fracture Population for the Reduction of Post-Operative Blood Transfusion

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 283 (actual)
• Sponsor: Lancaster General Hospital · Academic / Other
• Sex: All
• Age: 65 Years
• Healthy volunteers: Not accepted

Summary

The overall design of the study is a prospective, double-blinded, randomized study in the geriatric hip fracture population comparing those who receive intravenous tranexamic acid prior to incision to those who receive a placebo.

Detailed description

A significant portion of the geriatric hip fracture population have comorbidities including chronic kidney disease, congestive heart failure, ischemic heart disease, stroke, etc. These patients may be anemic prior to the surgery, and are at increased risk for further blood loss as a result of the fracture and surgical operation. However, intra-operative or post-operative blood transfusions also increase the risk of renal and cardiac complications in this population. Tranexamic acid (TXA) is an anti-fibrinolytic medication that has transformed total joint replacement management regarding blood loss prevention. Geriatric patients requiring emergent hip fracture repair may significantly benefit from routine administration of TXA prior to the procedure to decrease the risk of blood loss. Thus, treatment may further reduce the percentage of patients who experience blood transfusions and complications associated with transfusions. The investigators will examine if administration of TXA prior to incision in the geriatric hip fracture patient population decreases the risk of intra-operative or post-operative blood transfusions compared to placebo.

Conditions

• Hip Fractures

Interventions

Type	Name	Description
DRUG	Tranexamic Acid Injectable Solution	100 cc normal saline mixed with 1g of tranexamic acid in solution
OTHER	Placebo	100 cc normal saline

Timeline

• Start date: 2020-02-01
• Primary completion: 2022-12-09
• Completion: 2022-12-09
• First posted: 2019-04-23
• Last updated: 2024-10-10
• Results posted: 2024-10-10

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study