Status:
COMPLETED
Combined Topical Tranexamic Acid With Floseal® in Total Knee Arthroplasty
Lead Sponsor:
Chang Gung Memorial Hospital
Conditions:
Osteoarthritis, Knee
Eligibility:
All Genders
50-90 years
Phase:
PHASE4
Brief Summary
Our purpose of this study therefore is to conduct a prospective randomized controlled trial to investigate the blood-conservation effect of combined topical application of these two hemostatic agents ...
Detailed Description
Total knee arthroplasty (TKA) is associated with considerable blood loss and increasing needs for allogenic blood transfusion. Tranexamic acid (TXA), an inhibitor of fibrinolysis, was reportedly effec...
Eligibility Criteria
Inclusion
- Patients who have advanced knee osteoarthritis are scheduled to undergo primary, unilateral elective total knee replacement surgery
- Age \> 50 years and \< 90 years
- Failure of medical treatment or rehabilitation.
- Hemoglobin \> 11g/dl,
- No use of non-steroid anti-inflammatory agent one week before operation
Exclusion
- Preoperative Hemoglobin ≦11 g/dl
- History of infection or intraarticular fracture of the affective knee
- Renal function deficiency (GFR \<30 ml/min/1.73m2)which is relative contraindicated for chemical venous thromboembolism
- Elevated liver enzyme (AST/ALT level are more than twice normal range) , history of liver cirrhosis, impaired liver function(elevated total bilirubin level) and coagulopathy (including long-term use anticoagulant)
- History of deep vein thrombosis, ischemic heart disease or stroke
- Contraindications of tranexamic acid, floseal, or rivaroxaban
- Allergy to tranexamic acid, floseal, rivaroxaban, or the excipients
- History of heparin-induced thrombocytopenia (HIT)
- Coagulopathy or bleeding tendency caused by organ dysfunction, such as cirrhosis, bone marrow suppression etc.
- Patient who have active bleeding disorder, such as intracranial hemorrhage, upper GI bleeding, hematuria.
- Patients with known allergies to materials of bovine origin
Key Trial Info
Start Date :
September 12 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 30 2018
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT03328832
Start Date
September 12 2017
End Date
December 30 2018
Last Update
August 10 2021
Active Locations (1)
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1
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City, Taiwan