Kaolin-based Hemostatic Gauze in Total Knee Arthroplasty

• Status: Recruiting
• Trial end date: 2023-07-31
• Target enrollment: 0
• Participant gender: All

Summary

This study is to conduct a prospective randomized controlled trial to investigate the blood-conservation effect of combination of intravenous TXA and QCG in a primary TKA procedure.

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

Details

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

Criteria

Inclusion Criteria:

• Patients with advanced osteoarthritis of the knee and undergo primary unilateral minimally invasive TKA

• Age > 50 years and < 90 years

• Failure of medical treatment or rehabilitation

• Hemoglobin ≧ 11g/dl

• No use of non-steroid anti-inflammatory agent, antiplatelets or anticoagulants at least 3 days 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)

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, in which life-long oral anticoagulant are required.

6. Contraindications of tranexamic acid, or rivaroxaban

7. Allergy to tranexamic acid, kaolin, 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..