Phase 4
Completed N=70
Combined Topical Tranexamic Acid With Floseal® in Total Knee Arthroplasty
Osteoarthritis, Knee
Source: ClinicalTrials.gov NCT03328832 ↗
Enrolled (actual)
70
Serious AEs
0.0%
Results posted
Aug 2021
Primary outcomePrimary: Total Blood Loss After Operation — 678; 733 ml — p=0.276
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Total Blood Loss After Operation |
678; 733 | 0.276 |
| SECONDARY Blood Transfusion Rate |
1; 0 | 1 |
| SECONDARY Incidence of Thrombosis Events |
0; 0 | 1 |
Eligibility Criteria
Inclusion Criteria
- Patients who have advanced knee osteoarthritis are scheduled to undergo primary, unilateral elective total knee replacement surgery
- Age > 50 years and 11g/dl,
- No use of non-steroid anti-inflammatory agent one week before operation
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT03328832). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.