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

Phase 4TerminatedNCT03825939

NYU Langone Health52 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Blood Loss

Interventions

Intravenous PlaceboDRUG

IV 0.9% sterile saline

Intravenous Tranexamic AcidDRUG

1g TXA IVPB (intravenous piggyback)

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Winthrop University Hospital

Mineola, New York, United States

Outcomes

Primary Outcomes

Number of Participants Who Required a Blood Transfusion During Surgery

Multiple efforts were made to locate the study data, but were unsuccessful (study was terminated, data was not saved). No study data are available.

Time frame: operative period (average of 1 hour)

Secondary Outcomes

Change in Levels of Hematocrit: Pre-operative to Post-operative

Multiple efforts were made to locate the study data, but were unsuccessful (study was terminated, data was not saved). No study data are available.

Time frame: Day 3 or 4 post surgery

Length of Hospital Stay

Measured in Days

Time frame: At Hospital Discharge

Estimated Blood Loss During Surgery

Surgeon estimated blood loss

Time frame: Operative period (an average of 1 hour)

Change in Hemoglobin: Pre-operative to Post-operative

Measured in grams/deciliter

Time frame: Day 3 or 4 post surgery

Walking Distance Post Total Joint Arthroplasty of the Hip

Walking distance (feet) will be assessed and documented throughout the hospital stay

Time frame: 4 Days

Data from ClinicalTrials.gov

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