Non-inferiority Trial of Oral Tranexamic Acid vs. Intravenous Tranexamic Acid in Joint Replacement Surgery
Status unconfirmed · Phase 3
Conditions studied: Osteoarthritis, Blood Loss, Surgical, Blood Loss, Postoperative
In brief
The purpose of this research is to determine if the oral form of a medication (tranexamic acid) to reduce bleeding can be used in place of an intravenous (IV) form, to learn the best way to give tranexamic acid: either a pill by mouth, or a solution by vein.
Key facts
- Study ID
- NCT02438566
- Run by
- The New England Baptist Hospital
- People needed
- 118
- Starts
- 2015-04-01
- Expected to finish
- 2017-04-01
- Last updated by the study team
- 2016-03-22
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- To be included into this study, you must be undergoing hip or bilateral knee replacement surgery.
- You must be healthy enough to undergo joint replacement surgery.
- You must be able to understand and sign an informed consent.
- You must be at least 18 years of age.
You may not qualify if…
- You cannot be under 18 years of age.
- You cannot be undergoing revision hip or revision bilateral knee replacement surgery.
- You cannot be part of this study if you are allergic to the medication
- You cannot participate if you are on hemodialysis,
- You cannot participate if you have active coronary artery disease and if you have various vascular stents in place.
- You will also be excluded if you have ever had a blood clot (deep vein thrombosis (DVT), pulmonary embolism (PE)).
- You will also be excluded if you have ever had a cerebral or subarachnoid hemorrhage (brain bleeding), or stroke (cerebral vascular accident or transient ischemic attack).
- If you are on estrogen-containing medication (hormone replacement therapy or oral contraceptive) within 7 days of surgery, you cannot take part in this study.
Where it is running
- New England Baptist Hospital — Boston, Massachusetts, United States
Full record on ClinicalTrials.gov
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