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



Status:Recruiting
Healthy:No
Age Range:18 - Any
Updated:2/3/2019
Start Date:April 2015
End Date:December 2019
Contact:Michelle Mo
Email:michelle.mo@stonybrookmedicine.edu

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

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.

Inclusion Criteria

- All patients 18 years and older who are already scheduled for primary total joint
arthroplasty of the hip or knee

Exclusion Criteria for IV TXA administration

- Cardiac stent or ischemic stroke or coronary artery bypass graft (CABG)

- If patient is on anticoagulant, patient must have documented approval from a
cardiologist that patient can be removed from anticoagulant for total joint
arthroplasty procedure

- Renal impairment defined as serum Cr > 1.5 or Cr Clearance < 50 mL/min

- Severe ischemic heart disease

- Color blindness or problems with color vision

Criteria for Use of Topical TXA

- Topical TXA can be used in any patient meeting one of the exclusion criteria for IV
TXA administration (Section 5.3b) as there is minimal systemic absorption with topical
TXA

Absolute Exclusion Criteria

- History of deep vein thrombosis (DVT) or pulmonary embolism (PE)

- Known congenital thrombophilia

- History of thromboembolic or vascular disease

- Disseminated intravascular coagulation (DIC)

- History of seizures
We found this trial at
1
site
259 1st St
Mineola, New York 11501
(516) 663-0333
Winthrop University Hospital Founded in 1896 by a group of local physicians and concerned citizens,...
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Mineola, NY
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