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

NYU Langone Health

Status and phase: Terminated; Phase 4

Conditions: Blood Loss

Treatments: Drug: Intravenous Placebo; Drug: Intravenous Tranexamic Acid

Study type: Interventional

Funder types: Other

Identifiers

NCT03825939

WUH 592498-2

Details and patient eligibility

About

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

Full 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.

Enrollment: 52 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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52 participants in 3 patient groups, including a placebo group

Intravenous Tranexamic Acid

Experimental group

Description:

* 1g TXA administered intravenous piggyback at start of surgery OR * 1g TXA administered intravenous piggyback at start and at time of closure of surgery

Treatment:

Drug: Intravenous Tranexamic Acid

Intravenous Placebo

Placebo Comparator group

Description:

- IV 0.9% sterile saline

Treatment:

Drug: Intravenous Placebo

Intravenous Tranexamic Acid followed by Intravenous Placebo

Active Comparator group

Description:

* 1g TXA administered intravenous piggyback at start of surgery OR * 1g TXA administered intravenous piggyback at start and at time of closure of surgery * IV 0.9% sterile saline

Treatment:

Drug: Intravenous Tranexamic Acid

Drug: Intravenous Placebo