Non-inferiority Trial of Oral Tranexamic Acid vs. Intravenous Tranexamic Acid in Joint Replacement Surgery
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Arthritis, Osteoarthritis (OA), Hospital, Hospital |
| Therapuetic Areas: | Rheumatology, Other |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | April 2015 |
| End Date: | April 2017 |
Non-inferiority Trial of Oral Tranexamic Acid (OTA) vs. Intravenous Tranexamic Acid (IVTA) to Prevent Blood Loss in Joint Replacement Surgery
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.
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.
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. Tranexamic acid
is a medicine that reduces blood loss and reduces the need for blood transfusions in
surgery. This drug is not experimental and has been used widely to treat patients in many
settings, including orthopedic procedures, to reduce bleeding. This medication is now part
of the standard of care at many centers in the U.S. and around the world. Orthopedic
procedures have used iv tranexamic acid more often, but there are reasons to believe that
the oral form may be at least equivalent and perhaps better at lower cost to the health care
system. No other study has yet performed a systematic comparison to answer the question.
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. Tranexamic acid
is a medicine that reduces blood loss and reduces the need for blood transfusions in
surgery. This drug is not experimental and has been used widely to treat patients in many
settings, including orthopedic procedures, to reduce bleeding. This medication is now part
of the standard of care at many centers in the U.S. and around the world. Orthopedic
procedures have used iv tranexamic acid more often, but there are reasons to believe that
the oral form may be at least equivalent and perhaps better at lower cost to the health care
system. No other study has yet performed a systematic comparison to answer the question.
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
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