Combined Topical Tranexamic Acid With Floseal® in Total Knee Arthroplasty
NCT ID: NCT03328832
Last Updated: 2021-08-10
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
70 participants
INTERVENTIONAL
2017-09-12
2018-12-30
Brief Summary
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Detailed Description
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Besides, thrombin-based hemostatic agents, Floseal®(Baxter, Deerfield, Illinois), have been widely used in surgical procedure. Some recent studies demonstrated that topical use of Floseal® in primary TKA can reduce hemoglobin decline and calculated total blood loss after TKA. But other studies showed Floseal® does not reduce blood loss in TKA procedures.
We believe the topical use of hemostatic agent in patients with high risk of thromboembolism can avoid its systematic effect and decrease its potential perioperative risk of thromboembolic complications (arterial thrombosis, myocardial infarction and pulmonary embolism). Recently, there were some reports demonstrating the cost-effectiveness of topical application of TXA in TKA patients. The blood saving effect of topical application of TXA in primary TKA was similar with systemic administration. The mean total blood loss of topical route of TXA inTKA patients was 940-1295 ml in different reports which was still high for patients with high thromboembolic risks. However, the efficacy and safety of topical use of TXA in TKA patients with history of thromboembolic disease is still unclear. A more effective regimen for bleeding prophylaxis afer primary TKA is necessary.
We believe that combined topical applications of two hemostatic agents of different mechanisms can bring a synergistic effect in blood saving and does not increase the risk of thromboembolic disease after TKA.
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 in different time during surgery and the safety compared with single topical application of TKA in a primary TKA procedure.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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Combined topical TXA and Floseal
Floseal® was applied on potential bleeding sites before prosthesis implantation, and intraarticular application of topical tranexamic acid after capsule closure Oral rivaroxaban (10mg) QD on PostOp Day 1 to 14.
Topical tranexamic acid
Intraarticular application of tranexamic acid 3g in 60 ml normal saline into knee joint after closure of the joint capsule
Floseal®
Floseal® (Hemostatic matrix, 10ml, Baxter) was applied on potential bleeding sites: the femoral insertion of the posterior cruciate ligament, the lateral genicular artery after resection of the meniscus, the posterior capsule of the knee joint, the bony surfaces not covered by the implant as well as the pinholes (femur and tibia). The entire content of a 10 mL vial containing the active product (Floseal®) was used. The HM remained in place for 3 minutes and was then gently rinsed from the knee as recommended by the manufacturer (Baxter)
rivaroxaban (10mg)
Oral rivaroxaban (10mg) QD on PostOp Day 1 to 14.
Topical TXA alone
Intraarticular application of topical tranexamic acid after capsule closure Oral rivaroxaban (10mg) QD on PostOp Day 1 to 14.
Topical tranexamic acid
Intraarticular application of tranexamic acid 3g in 60 ml normal saline into knee joint after closure of the joint capsule
rivaroxaban (10mg)
Oral rivaroxaban (10mg) QD on PostOp Day 1 to 14.
Interventions
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Topical tranexamic acid
Intraarticular application of tranexamic acid 3g in 60 ml normal saline into knee joint after closure of the joint capsule
Floseal®
Floseal® (Hemostatic matrix, 10ml, Baxter) was applied on potential bleeding sites: the femoral insertion of the posterior cruciate ligament, the lateral genicular artery after resection of the meniscus, the posterior capsule of the knee joint, the bony surfaces not covered by the implant as well as the pinholes (femur and tibia). The entire content of a 10 mL vial containing the active product (Floseal®) was used. The HM remained in place for 3 minutes and was then gently rinsed from the knee as recommended by the manufacturer (Baxter)
rivaroxaban (10mg)
Oral rivaroxaban (10mg) QD on PostOp Day 1 to 14.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Age \> 50 years and \< 90 years
3. Failure of medical treatment or rehabilitation.
4. Hemoglobin \> 11g/dl,
5. No use of non-steroid anti-inflammatory agent one week before operation
Exclusion Criteria
2. History of infection or intraarticular fracture of the affective knee
3. Renal function deficiency (GFR \<30 ml/min/1.73m2)which is relative contraindicated for chemical venous thromboembolism
4. 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)
5. History of deep vein thrombosis, ischemic heart disease or stroke
6. Contraindications of tranexamic acid, floseal, or rivaroxaban
7. Allergy to tranexamic acid, floseal, rivaroxaban, or the excipients
8. History of heparin-induced thrombocytopenia (HIT)
9. Coagulopathy or bleeding tendency caused by organ dysfunction, such as cirrhosis, bone marrow suppression etc.
10. Patient who have active bleeding disorder, such as intracranial hemorrhage, upper GI bleeding, hematuria.
11. Patients with known allergies to materials of bovine origin
50 Years
90 Years
ALL
Yes
Sponsors
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Chang Gung Memorial Hospital
OTHER
Responsible Party
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Wang Jun-Wen
Professor
Principal Investigators
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Jun-Wen Wang, MD
Role: STUDY_CHAIR
Chang Gung Memorial Hospital
Locations
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Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City, , Taiwan
Countries
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References
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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201601271A0
Identifier Type: -
Identifier Source: org_study_id
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