Weighted Versus Uniform Dose of Tranexamic Acid in Patients Undergoing Primary, Knee Arthroplasty
Completed · Phase 2/Phase 3
Conditions studied: Osteoarthritis, Intraoperative Bleeding
In brief
Hypotheses: Primary - A weighted dose of 20 mg/kg of tranexamic acid will be more efficacious than a single uniform dose of 1 gram in primary total knee arthroplasty (TKA) cases. This includes having a greater impact on decreasing blood loss without increasing the occurrence of adverse thromboembolic events in patients undergoing primary, elective total knee arthroplasty. Secondary - TA will decrease blood loss more effectively in women than in men undergoing this procedure.
Key facts
- Study ID
- NCT01651806
- Run by
- Rush University Medical Center
- People needed
- 65
- Starts
- 2012-05-01
- Expected to finish
- 2015-03-01
- Last updated by the study team
- 2017-12-13
Who can join
Age: 18 and older, up to 80. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Patients must be male or female of any race
- Ages 18-80 years old
- Patients must be undergoing an elective, primary knee arthroplasty
- Patients must be able to understand and willing to cooperate with study procedures
- Patients must be able to provide written and verbal informed consent
You may not qualify if…
- Allergy or intolerance to the study materials
- History of a venous thromboembolic event being treated with life-long anticoagulation
- Patients with a known congenital thrombophilia
- Patients who have had a venous thromboembolic event within the 12 months preceding surgery
- History of any substance abuse or dependence within the last 6 months
- Failure in collecting a required data point during study
- Those patients not indicated for knee replacement surgery including, pregnant women, those not cleared medically for the procedure and patients without significant radiographic evidence of degenerative joint disease.
- Patient using autologous blood transfusion
Where it is running
- Rush University Medical Center — Chicago, Illinois, United States
Full record on ClinicalTrials.gov
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