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

Phase 4

Terminated

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.

Recruitment & Eligibility

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Arm && Interventions

Group	Intervention	Description
Intravenous Placebo	Intravenous Placebo	- IV 0.9% sterile saline
Intravenous Tranexamic Acid	Intravenous Tranexamic Acid	* 1g TXA administered intravenous piggyback at start of surgery OR * 1g TXA administered intravenous piggyback at start and at time of closure of surgery
Intravenous Tranexamic Acid followed by Intravenous Placebo	Intravenous Placebo	* 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
Intravenous Tranexamic Acid followed by Intravenous Placebo	Intravenous Tranexamic Acid	* 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

Primary Outcome Measures

Name	Time	Method
Number of Participants Who Required a Blood Transfusion During Surgery	operative period (average of 1 hour)	Multiple efforts were made to locate the study data, but were unsuccessful (study was terminated, data was not saved). No study data are available.

Secondary Outcome Measures

Name	Time	Method
Walking Distance Post Total Joint Arthroplasty of the Hip	4 Days	Walking distance (feet) will be assessed and documented throughout the hospital stay
Length of Hospital Stay	At Hospital Discharge	Measured in Days
Change in Levels of Hematocrit: Pre-operative to Post-operative	Day 3 or 4 post 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.
Estimated Blood Loss During Surgery	Operative period (an average of 1 hour)	Surgeon estimated blood loss
Change in Hemoglobin: Pre-operative to Post-operative	Day 3 or 4 post surgery	Measured in grams/deciliter

Locations (1): Winthrop University Hospital
🇺🇸
Mineola, New York, United States