Evaluating the Use of Tranexamic Acid (TXA) in Total Joint Arthroplasty
Primary Purpose
Blood Loss
Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Intravenous Placebo
Intravenous Tranexamic Acid
Sponsored by
About this trial
This is an interventional treatment trial for Blood Loss focused on measuring Total hip arthroplasty, Total knee arthroplasty
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
Sites / Locations
- Winthrop University Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Placebo Comparator
Active Comparator
Arm Label
Intravenous Tranexamic Acid
Intravenous Placebo
Intravenous Tranexamic Acid followed by Intravenous Placebo
Arm 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
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
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Length of Hospital Stay
Measured in Days
Estimated Blood Loss During Surgery
Surgeon estimated blood loss
Change in Hemoglobin: Pre-operative to Post-operative
Measured in grams/deciliter
Walking Distance Post Total Joint Arthroplasty of the Hip
Walking distance (feet) will be assessed and documented throughout the hospital stay
Full Information
NCT ID
NCT03825939
First Posted
December 23, 2015
Last Updated
August 31, 2021
Sponsor
NYU Langone Health
Collaborators
Winthrop University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03825939
Brief Title
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
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Terminated
Why Stopped
Lack of patient enrollment due to only one surgeon that was enrolling.
Study Start Date
April 21, 2015 (Actual)
Primary Completion Date
July 26, 2016 (Actual)
Study Completion Date
September 6, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health
Collaborators
Winthrop University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Blood Loss
Keywords
Total hip arthroplasty, Total knee arthroplasty
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
52 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intravenous Tranexamic Acid
Arm Type
Experimental
Arm 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
Arm Title
Intravenous Placebo
Arm Type
Placebo Comparator
Arm Description
- IV 0.9% sterile saline
Arm Title
Intravenous Tranexamic Acid followed by Intravenous Placebo
Arm Type
Active Comparator
Arm 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
Intervention Type
Drug
Intervention Name(s)
Intravenous Placebo
Other Intervention Name(s)
Saline
Intervention Description
IV 0.9% sterile saline
Intervention Type
Drug
Intervention Name(s)
Intravenous Tranexamic Acid
Other Intervention Name(s)
Tranexamic Acid
Intervention Description
1g TXA IVPB (intravenous piggyback)
Primary Outcome Measure Information:
Title
Number of Participants Who Required a Blood Transfusion During Surgery
Description
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 Outcome Measure Information:
Title
Change in Levels of Hematocrit: Pre-operative to Post-operative
Description
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
Title
Length of Hospital Stay
Description
Measured in Days
Time Frame
At Hospital Discharge
Title
Estimated Blood Loss During Surgery
Description
Surgeon estimated blood loss
Time Frame
Operative period (an average of 1 hour)
Title
Change in Hemoglobin: Pre-operative to Post-operative
Description
Measured in grams/deciliter
Time Frame
Day 3 or 4 post surgery
Title
Walking Distance Post Total Joint Arthroplasty of the Hip
Description
Walking distance (feet) will be assessed and documented throughout the hospital stay
Time Frame
4 Days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jan A Koenig, M.D.
Organizational Affiliation
Winthrop University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Winthrop University Hospital
City
Mineola
State/Province
New York
ZIP/Postal Code
11501
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Evaluating the Use of Tranexamic Acid (TXA) in Total Joint Arthroplasty
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