Randomized Controlled Trial of Tranexamic Acid in Total Knee Arthroplasty: Intravenous vs. Topical
Completed · Phase 4
Conditions studied: Osteoarthritis
In brief
The purpose of this study is to determine whether topical or intravenous administration of tranexamic acid during unilateral total knee replacement is more effective at reducing bleeding in the first 24 hours following surgery. Tranexamic acid is a synthetic drug that has been shown to reduce blood drain output and the need for blood transfusions in both its topical and intravenous forms and is commonly used in orthopedic surgery. We hypothesize that IV and topical administration of tranexamic acid will be equally good at reducing the loss of blood and the need for transfusion immediately following total knee replacement.
Key facts
- Study ID
- NCT01940523
- Run by
- Hospital for Special Surgery, New York
- People needed
- 640
- Starts
- 2013-05-01
- Expected to finish
- 2017-05-16
- Last updated by the study team
- 2019-11-27
Who can join
Age: 18 and older, up to 100. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Primary total knee replacmeent
- Osteoarthritis
- Unilateral
You may not qualify if…
- Revision surgery
- Donated preoperative autologous blood
- On chronic anticoagulation medication such as Coumadin, Xarelto, Plavix, or Aspirin (other than 81mg)
- Preoperative hepatic or renal dysfunction
- Diagnosis of inflammatory disease
- Diagnosis of inflammatory arthritis
- Pregnant
- Breastfeeding
- Preoperative hemoglobin <10g/dL
- International Normalized Ratio>1.4
- Abnormal Partial Thromboplastin Time
- Preoperative platelet count of <150,000mm\^3
- Creatinine > 1.4
Where it is running
- Mayo Clinic — Rochester, Minnesota, United States
- Hospital for Special Surgery — New York, New York, United States
Full record on ClinicalTrials.gov
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