NCT03182751

Does Early Administration of Tranexamic Acid Reduce Blood Loss and Perioperative Transfusion Requirement

Does Early Administration of Tranexamic Acid Reduce Blood Loss and Perioperative Transfusion Requirement in Low Energy Hip Fracture Patients?

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 128 (actual)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Intertrochanteric hip fractures typically result in blood loss from the fracture and require surgery that can cause further blood loss. This study is being done to look at a medication called tranexamic acid which may reduce blood loss and the need for blood transfusions associated with surgery.

Detailed description

The use of TXA in orthopedic trauma patients is an area of current research interest. A 2010 prospective randomized, controlled trial of perioperative TXA demonstrated reduction in transfusion requirements for intertrochanteric hip fractures treated with short, cephalomedullary nails. This was clinically, though not statistically, significant. Investigators recently conducted a randomized, controlled trial at this institution to evaluated the use of TXA in patients with femoral neck fractures treated with hemiarthroplasty or total hip arthroplasty and found clinically, albeit not statistically, significant reduction in transfusion requirement (accepted for publication). Perhaps tempering the effect seen with perioperative administration of TXA is the blood loss that occurs prior to surgery, the so-called "hidden" blood loss that can be as substantial as 1/3 of total blood loss from a hip fracture. This raises the question whether administration of tranexamic acid at the time of initial presentation after fracture could improve the perioperative care of these patients by decreasing the proportion of patients requiring transfusion and decreasing total blood loss.

Conditions

• Hip Fractures
• Intertrochanteric Fractures

Interventions

Type	Name	Description
DRUG	Tranexamic Acid (TXA)	Intravenously via bolus dose of 1g over ten minutes and an additional 1g over the subsequent 8 hours
DRUG	Placebo	Looks exactly like the study drug, but it contains no active ingredient

Timeline

• Start date: 2018-04-02
• Primary completion: 2022-05-24
• Completion: 2022-05-24
• First posted: 2017-06-09
• Last updated: 2023-03-30
• Results posted: 2023-03-30

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study