Combined Topical Tranexamic Acid With Floseal® in Total Knee Arthroplasty

• Status: Completed
• Trial end date: 2018-12-30
• Target enrollment: 0
• Participant gender: All

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 in different time during surgery and the safety compared with single topical application of TKA in a primary TKA procedure

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Chang Gung Memorial Hospital
• Treatments: Rivaroxaban; Thrombin; Tranexamic Acid; Tranylcypromine

Criteria

Inclusion Criteria:

1. Patients who have advanced knee osteoarthritis are scheduled to undergo primary, unilateral elective total knee replacement surgery

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:

1. Preoperative Hemoglobin ≦11 g/dl

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