Status:
TERMINATED
Evaluating the Use of Tranexamic Acid (TXA) in Total Joint Arthroplasty
Lead Sponsor:
NYU Langone Health
Collaborating Sponsors:
Winthrop University Hospital
Conditions:
Blood Loss
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
April 21 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 6 2016
Estimated Enrollment :
52 Patients enrolled
Trial Details
Trial ID
NCT03825939
Start Date
April 21 2015
End Date
September 6 2016
Last Update
September 28 2021
Active Locations (1)
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1
Winthrop University Hospital
Mineola, New York, United States, 11501