Clinical trial NCT03825939: Evaluating the Use of Tranexamic Acid (TXA) in Total Joint Arthroplasty
Official title: Evaluating the Use of Tranexamic Acid (TXA) in Total Joint Arthroplasty
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Blood Loss
Keywords: Total hip arthroplasty
Total knee arthroplasty
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
Collaborators: name: Winthrop University Hospital
First posted: 2019-02-01
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants Who Required a Blood Transfusion During Surgery
timeFrame: operative period (average of 1 hour)
Secondary outcomes:
measure: Change in Levels of Hematocrit: Pre-operative to Post-operative
timeFrame: Day 3 or 4 post surgery
measure: Length of Hospital Stay
timeFrame: At Hospital Discharge
measure: Estimated Blood Loss During Surgery
timeFrame: Operative period (an average of 1 hour)
measure: Change in Hemoglobin: Pre-operative to Post-operative
timeFrame: Day 3 or 4 post surgery
measure: Walking Distance Post Total Joint Arthroplasty of the Hip
timeFrame: 4 Days
Other outcomes:
Locations:
city: Mineola
country: United States
facility: Winthrop University Hospital
state: New York
Study officials:
affiliation: Winthrop University Hospital
name: Jan A Koenig, M.D.
role: PRINCIPAL_INVESTIGATOR
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