Topical Tranexamic Acid and Floseal® in Total Knee Arthroplasty

• Register: ClinicalTrials.gov
• Last refreshed on: 22 August 2016
• Main ID: NCT02865174
• Date of registration: 09/08/2016
• Prospective Registration: Yes
• Primary sponsor: Chang Gung Memorial Hospital
• Public title: Topical Tranexamic Acid and Floseal® in Total Knee Arthroplasty
• Scientific title: Comparison of Topical Tranexamic Acid and Floseal® on Blood Loss After Total Knee Arthroplasty in Patients With a Thromboembolic Risk
• Date of first enrolment: September 2016
• Target sample size: 90
• Recruitment status: Not yet recruiting
• URL: https://clinicaltrials.gov/show/NCT02865174
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention
• Phase: Phase 4

Countries of recruitment

Taiwan

Contacts

• Name: Jun-Wen Wang
• Affiliation: Chang Gung Memorial Hospital

• Name: Jun-Wen MD Wang

Key inclusion & exclusion criteria

Inclusion Criteria:

History of ischemic heart disease, stroke, or VTE high risk group, such as obesity,
varicose vein of the leg, previous history of PE or DVT, hypercoagulability, recent or
ongoing treatment for cancer.

After cardiologist or neurologist's evaluation, patients who was classified as low-risk of
perioperative risk Advanced knee osteoarthritis, Failure of medical treatment or
rehabilitation. Hemoglobin > 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) Elevated liver enzyme,
history of liver cirrhosis, impaired liver function and coagulopathy



Age minimum: 50 Years
Age maximum: 85 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Osteoarthritis, Knee

Intervention(s)

Drug: Enoxaparin

Drug: Floseal®

Drug: Topical tranexamic acid

Primary Outcome(s)

Decrease of hemoglobin level after operation [Time Frame: From the operation to the postoperative day 14]

Total blood loss after operation [Time Frame: From the operation to the postoperative day 3 or 4]

Secondary Outcome(s)

Incidence of any non-major bleeding [Time Frame: within 30 days of the operation]

Incidence of any thrombotic events [Time Frame: within 30 days of the operation]

Incidence of major postoperative bleeding [Time Frame: within 30 days of the operation]

Incidence of wound infection after surgery [Time Frame: within 30 days of the operation]

Secondary ID(s)

NMMRPG8F0191

Source(s) of Monetary Support

Please refer to primary and secondary sponsors