Safety of Topical Tranexamic Acid in Total Joint Arthroplasty in High Risk Patients

Brief Summary
To evaluate whether there is a difference in symptomatic thromboembolism events in the subset of patients with a history of, or risk factors for thromboembolic disease for topically applied tranexamic acid in total joint arthroplasty.
Brief Title
Safety of Topical Tranexamic Acid in Total Joint Arthroplasty in High Risk Patients
Detailed Description
Tranexamic acid (TXA) has been used successfully to stop bleeding after dental procedures, removal of tonsils, prostate surgery, heavy menstrual bleeding, and eye injuries, as well as in patients with hemophilia. Intravenous TXA has also been shown to reduce blood loss, reduce transfusion requirements, and decrease length of stay for patients undergoing total knee arthroplasty and total hip arthroplasty. These benefits occur without increasing risks of thromboembolism events such as pulmonary embolism, deep venous thrombosis, myocardial infarctions, and cerebrovascular events in patients without history of, or risk factors for thromboembolic disease. Topical TXA in TJA has also been demonstrated to show the above benefits without any increase risks, as well as systemic absorption of the medication that is below the effective therapeutic plasma concentration.

Preliminary retrospective studies has demonstrated that IV TXA to be safe and effective in patients with risk factors for thromboembolic events and patients with American Society of Anesthesiologists score III or IV.

Currently, there are no prospective studies on the use of either IV or topical TXA in these higher risk patients. The goal of this study is to evaluate whether there is a difference in symptomatic thromboembolism events in the subset of patients with a history of, or risk factors for thromboembolic disease for topically applied TXA in total joint arthroplasty (TJA).
Completion Date
Completion Date Type
Estimated
Conditions
Pulmonary Embolism
Deep Vein Thrombosis
Stroke
Myocardial Infarction
Eligibility Criteria
Inclusion Criteria:

Presence of one or more of seven risk factors for thromboembolic events - Prior DVT, PE, MI, CVA, coronary artery stent placement, CABG, or prothrombotic condition (Factor V Leiden deficiency, protein C deficiency, antiphospholipid syndrome, etc).

Exclusion Criteria:

Simultaneous bilateral, hip resurfacing, partial knee, and revision arthroplasties
Inclusion Criteria
Inclusion Criteria:

Presence of one or more of seven risk factors for thromboembolic events - Prior DVT, PE, MI, CVA, coronary artery stent placement, CABG, or prothrombotic condition (Factor V Leiden deficiency, protein C deficiency, antiphospholipid syndrome, etc).

Gender
All
Gender Based
false
Healthy Volunteers
No
Last Update Submit Date
Maximum Age
100 Years
Minimum Age
50 Years
NCT Id
NCT02644473
Org Class
Other
Org Full Name
Albert Einstein College of Medicine
Org Study Id
2015-5435
Overall Status
Withdrawn
Phases
Phase 4
Primary Completion Date
Primary Completion Date Type
Estimated
Primary Outcomes
Outcome Measure
Deep Vein Thrombosis
Outcome Time Frame
1 month
Outcome Measure
Pulmonary Embolism
Outcome Time Frame
1 month
Outcome Measure
Stroke
Outcome Time Frame
1 month
Outcome Measure
Myocardial infarction
Outcome Time Frame
1 month
Start Date
Start Date Type
Estimated
Status Verified Date
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
100
Minimum Age Number (converted to Years and rounded down)
50
Investigators
Investigator Type
Principal Investigator
Investigator Name
Sunjin Kim
Investigator Email
sukim@montefiore.org
Investigator Phone
347-577-4484
Categories Mesh Debug
Brain, Spinal Cord & Nervous System --- STROKE
Heart/Cardiovascular --- MYOCARDIAL INFARCTION
Lung & Chest Cancers --- LUNG DISEASES
COVID-19 --- LUNG DISEASES
Lung --- LUNG DISEASES
Asthma and Other Respiratory Diseases --- RESPIRATORY TRACT DISEASES
Lung & Chest Cancers --- RESPIRATORY TRACT DISEASES
COVID-19 --- RESPIRATORY TRACT DISEASES
Lung --- RESPIRATORY TRACT DISEASES
Blood & Bone Marrow Cancers --- VASCULAR DISEASES
Heart/Cardiovascular --- VASCULAR DISEASES
Blood Disorders --- CARDIOVASCULAR DISEASES
Blood & Bone Marrow Cancers --- CARDIOVASCULAR DISEASES
Heart/Cardiovascular --- CARDIOVASCULAR DISEASES
Brain, Spinal Cord & Nervous System --- THROMBOSIS
Brain, Spinal Cord & Nervous System --- CEREBROVASCULAR DISORDERS
Alzheimer's --- BRAIN DISEASES
Brain, Spinal Cord & Nervous System --- BRAIN DISEASES
Brain, Spine & Nerve Cancers --- BRAIN DISEASES
Alzheimer's --- CENTRAL NERVOUS SYSTEM DISEASES
Brain, Spinal Cord & Nervous System --- CENTRAL NERVOUS SYSTEM DISEASES
Brain, Spine & Nerve Cancers --- CENTRAL NERVOUS SYSTEM DISEASES
Brain, Spinal Cord & Nervous System --- NERVOUS SYSTEM DISEASES
Brain, Spine & Nerve Cancers --- NERVOUS SYSTEM DISEASES
Heart/Cardiovascular --- MYOCARDIAL ISCHEMIA
Brain, Spinal Cord & Nervous System --- HEART DISEASES
Heart/Cardiovascular --- HEART DISEASES
Heart/Cardiovascular --- INFARCTION
Heart/Cardiovascular --- ISCHEMIA
MeSH Terms
PULMONARY EMBOLISM
VENOUS THROMBOSIS
STROKE
MYOCARDIAL INFARCTION
LUNG DISEASES
RESPIRATORY TRACT DISEASES
EMBOLISM
EMBOLISM AND THROMBOSIS
VASCULAR DISEASES
CARDIOVASCULAR DISEASES
THROMBOSIS
CEREBROVASCULAR DISORDERS
BRAIN DISEASES
CENTRAL NERVOUS SYSTEM DISEASES
NERVOUS SYSTEM DISEASES
MYOCARDIAL ISCHEMIA
HEART DISEASES
INFARCTION
ISCHEMIA
PATHOLOGIC PROCESSES
PATHOLOGICAL CONDITIONS, SIGNS AND SYMPTOMS
NECROSIS
TRANEXAMIC ACID
SALINE SOLUTION
CYCLOHEXANECARBOXYLIC ACIDS
ACIDS, CARBOCYCLIC
CARBOXYLIC ACIDS
ORGANIC CHEMICALS
CRYSTALLOID SOLUTIONS
ISOTONIC SOLUTIONS
SOLUTIONS
PHARMACEUTICAL PREPARATIONS