NCT03825939

Evaluating the Use of Tranexamic Acid (TXA) in Total Joint Arthroplasty

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 52 (actual)
• Sponsor: NYU Langone Health · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This research study aims to study the use of tranexamic acid (TXA) in total joint replacement (arthroplasty) of the hip (THR) and knee (TKR).

Detailed description

Tranexamic Acid (TXA) is given to stop or reduce heavy bleeding. It works by stopping clots from breaking down and by decreasing unwanted bleeding. It is used in many types of surgeries to help reduce surgical complications such as blood loss and blood transfusions. In orthopaedic surgeries, such as in total hip and knee replacements, TXA has been shown to effectively reduce blood loss and transfusion requirements without an increased risk of side effects such as deep venous thrombosis (DVT) or pulmonary embolism (PE). The ability to decrease blood loss is crucial, as other studies have shown that reducing blood loss decreases morbidity and mortality in patients. Although, many TXA dosing regimens have been studied - all of which have been useful at reducing blood loss and decreasing transfusion requirements - the best TXA dosing regimen and the most cost-effective method of TXA administration for patients have yet to be determined. Moreover, a thorough and rigorous study on the use and effects of topical and intravenous TXA and the effect of TXA on patient outcomes has yet to be conducted. Therefore, this research study aims to address those concerns in order to understand how best to use TXA to reduce surgical complications in patients undergoing total joint replacements.

Conditions

• Blood Loss

Interventions

Type	Name	Description
DRUG	Intravenous Placebo	IV 0.9% sterile saline
DRUG	Intravenous Tranexamic Acid	1g TXA IVPB (intravenous piggyback)

Timeline

• Start date: 2015-04-21
• Primary completion: 2016-07-26
• Completion: 2016-09-06
• First posted: 2019-02-01
• Last updated: 2021-09-28
• Results posted: 2021-09-28

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study