Status:
UNKNOWN
Study Comparing Topical Versus Intravenous Tranexamic Acid in Anterior Total Hip Arthroplasty
Lead Sponsor:
Albany Medical College
Conditions:
Tranexamic Acid Adverse Reaction
Eligibility:
All Genders
18-80 years
Phase:
PHASE4
Brief Summary
Brief Summary Title: Prospective Randomized Trial Comparing Topical Versus Intravenous Tranexamic Acid (TXA) in Anterior (Total hip arthroplasty) Several strategies have been used to reduce transfusio...
Detailed Description
Detailed Description Prospective Randomized Study Comparing Topical versus Intravenous Tranexamic Acid in Anterior Total Hip Arthroplasty A. Study Background and Purpose Hip and knee arthroplasty is o...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- To be eligible to participate in the study, subjects must meet the following criteria:
- Males or females age \> 18 years and \<80 years
- Informed consent
- Diagnosis of primary osteoarthritis or osteonecrosis
- Previous history of contralateral hip or knee arthroplasty will not be excluded from the study Exclusion criteria
- Subjects who meet any of the following criteria will NOT be eligible to participate in the study:
- Unable to comply with study requirements i.e unable to complete first follow-up visit at 4 weeks or if they are unable to follow-up.
- Has an active joint infection\\
- Immuno-suppression, e.g., human immunodeficiency virus (HIV) infection, s/p organ transplantation, receipt of steroids for \> 10 days at \> 10 mg of prednisone equivalent daily within the 90 days prior to enrollment
- Chronic hepatitis B virus (HBV) or hepatitis C virus (HCV) infection
- Body mass index \> 45
- Life expectancy \< 6 months
- Renal insufficiency (serum creatinine \>2.5 mg/dl)
- Pre-operative Hemoglobin \<8 gm/dl
- Congenital and acquired coagulopathy
- Patients on pre-operative therapeutic anticoagulation
- Patients who need post-operative therapeutic anticoagulation
- Pregnancy and nursing mothers or women who are expected to nurse their babies within one month of surgery
- History of thromboembolism, stroke, transient ischemic attack, traumatic brain injury, subdural, or subarachnoid hemorrhage
- History of reported allergy to tranexamic acid
- Uncontrolled Hypertension
- Non-steroidal antiinflammatory use within 3 weeks of surgery other than Celebrex.
- Patients who continue the use of aspirin and have not stopped for more than 7 days prior to surgery.
- Patients who need to be on any anticoagulation other than aspirin 325 mg BID will be excluded from the study.
- Prisoners will be excluded from the study.
- Patients with history of acquired defective color vision
- Plan for staged bilateral total hip procedures within 14 days
- Family history of thromboembolism
- Patient unable to receive spinal anesthesia
Exclusion
Key Trial Info
Start Date :
July 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2019
Estimated Enrollment :
114 Patients enrolled
Trial Details
Trial ID
NCT03359525
Start Date
July 1 2017
End Date
December 31 2019
Last Update
December 2 2017
Active Locations (1)
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1
Albany Medical Center
Albany, New York, United States, 12208