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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oral Tranexamic Acid (OTA) | Active Comparator | Subjects will be randomized 1:1 to receive either IVTA or OTA with corresponding placebos. OTA will be given as 1950 mg 1-2 hours prior to OR and 1950 mg 2 hours after surgical close, before discharge from PACU. |
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| Intravenous Tranexamic Acid (IVTA) | Active Comparator | Subjects will be randomized 1:1 to receive either IVTA or OTA with corresponding placebos. IVTA will be given as 1 g intravenously at time of first incision (THA or bTKA without tourniquet) or just before 1st tourniquet application (bTKA), and then again, 1 g after final surgery closure. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tranexamic Acid (Oral) | Drug | OTA will be given as 1950 mg 1-2 hours prior to OR and 1950 mg 2 hours after surgical close, before discharge from PACU. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Lower number of units of blood required for transfusion. | Lower number of units of blood required for transfusion in the OR and post-operatively, hospital-wide. | 2 Years |
| Measure | Description | Time Frame |
|---|---|---|
| Lower incidences of patients requiring blood transfusion. | Lower incidences of patients requiring blood transfusion in the OR, or post-operatively. | 2 Years |
| Lower Blood Loss in Patients | Lower amounts of blood loss in patients during in surgery, and post-operatively. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kenneth Bauer, MD | New England Baptist Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| New England Baptist Hospital | Boston | Massachusetts | 02120 | United States |
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|
| Tranexamic Acid (Intravenous) | Drug | IVTA will be given as 1 g intravenously at time of first incision (THA or bTKA without tourniquet) or just before 1st tourniquet application (bTKA), and then again, 1 g after final surgery closure. |
|
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| Hospital Stay: 1-3 days. |
| Length of Stay | Potential for a shorter length of hospital stay for post-surgical patients. | 1-3 Days |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D016063 | Blood Loss, Surgical |
| D019106 | Postoperative Hemorrhage |
| D006470 | Hemorrhage |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007431 | Intraoperative Complications |
| D011183 | Postoperative Complications |
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| ID | Term |
|---|---|
| D014148 | Tranexamic Acid |
| ID | Term |
|---|---|
| D003509 | Cyclohexanecarboxylic Acids |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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