Randomized Controlled Trial of Tranexamic Acid in Total Knee Arthroplasty: Intravenous vs. Topical
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Arthritis, Osteoarthritis (OA) |
| Therapuetic Areas: | Rheumatology |
| Healthy: | No |
| Age Range: | 18 - 100 |
| Updated: | 3/11/2017 |
| Start Date: | May 2013 |
| End Date: | April 14, 2017 |
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.
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.
This randomized controlled trial compares the blood loss of patients undergoing unilateral
total knee replacements who randomly receive either the topical or the intravenous form of
tranexmamic acid during surgery. Patients in the intravenous arm of the study will receive 1
gram of tranexamic acid in 10 milliliters of solution prior to inflation of the tourniquet
and 1 gram of tranexamic acid in 10 milliliters of solution during closure. For patients in
the topical arm of the study, prior to the release of the tourniquet they will receive 3
grams of tranexamic acid in 75ccs of solution directly on the site of the incision.
The primary result measurement will be blood drain output from the knee at 24 hours after
surgery.
total knee replacements who randomly receive either the topical or the intravenous form of
tranexmamic acid during surgery. Patients in the intravenous arm of the study will receive 1
gram of tranexamic acid in 10 milliliters of solution prior to inflation of the tourniquet
and 1 gram of tranexamic acid in 10 milliliters of solution during closure. For patients in
the topical arm of the study, prior to the release of the tourniquet they will receive 3
grams of tranexamic acid in 75ccs of solution directly on the site of the incision.
The primary result measurement will be blood drain output from the knee at 24 hours after
surgery.
Inclusion Criteria:
- Primary total knee replacmeent
- Osteoarthritis
- Unilateral
Exclusion Criteria:
- 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
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