Osteoarthritis
Conditions
Keywords
total knee arthroplasty, total knee replacement, tranexamic acid, osteoarthritis, degenerative joint disease
Brief summary
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.
Detailed description
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.
Interventions
3 vials of tranexamic acid (1g tranexamic acid in 10cc each) must be mixed in the operating room by the team at the start of surgery with 45cc of saline solution (for a total of 3g tranexamic acid in 75mL solution). This solution will be applied to the open joint surfaces with two 60mL syringes (one with 60mL and one with 15m). The solution will be left in contact with the tissues for five minutes. The surgeon will suction away excess solution. The site may be irrigated before or after the tranexamic acid bath as long as the solution is in contact for at least five full minutes. After that, the tourniquet will be released and the rest of the surgery will proceed according to the standard of care.
DRUGIntravenous Tranexamic Acid
1 vial (1g of IV tranexamic acid in 10mL solution) will be administered prior to inflation of the tourniquet. A second 1g dose of IV tranexamic acid will be given during initiation of the closure after the tourniquet is deflated and during closure.
Sponsors
Mayo Clinic
Hospital for Special Surgery, New York
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total Blood Loss | during surgery | The amount of blood lost during surgery is the primary outcome measure. Blood loss is determineusing an equation that calculates the patient's blood volume based on their height and weight, then multiplies the patient's blood volume by the change in their hematocrit after surgery compared to before surgery. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Drain Output | from end of surgery to 24 hours postoperatively | The amount of blood collected by a drain attached to the knee is measured 24 hours after surgery. |
| The Number Patients Requiring a Transfusion | over course of hospital stay (averaging three days) | TThe number Patients requiring a transfusion over the course of the patient's hospital stay. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Topical Tranexamic Acid 3 vials of tranexamic acid (1g tranexamic acid in 10cc each) must be mixed in the operating room by the team at the start of surgery with 45cc of saline solution (for a total of 3g tranexamic acid in 75mL solution). This solution will be applied to the open joint surfaces with two 60mL syringes (one with 60mL and one with 15m).
Topical Tranexamic Acid: 3 vials of tranexamic acid (1g tranexamic acid in 10cc each) must be mixed in the operating room by the team at the start of surgery with 45cc of saline solution (for a total of 3g tranexamic acid in 75mL solution). This solution will be applied to the open joint surfaces with two 60mL syringes (one with 60mL and one with 15m). The solution will be left in contact with the tissues for five minutes. | 320 |
| Intravenous Tranexamic Acid 1 vial (1g of IV tranexamic acid in 10mL solution) will be administered prior to inflation of the tourniquet. A second 1g dose of IV tranexamic acid will be given during initiation of the closure after the tourniquet is deflated and during closure.
Intravenous Tranexamic Acid: 1 vial (1g of IV tranexamic acid in 10mL solution) will be administered prior to inflation of the tourniquet. A second 1g dose of IV tranexamic acid will be given during initiation of the closure after the tourniquet is deflated and during closure. | 320 |
| Total | 640 |
Baseline characteristics
| Characteristic | Topical Tranexamic Acid | Intravenous Tranexamic Acid | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 174 Participants | 169 Participants | 343 Participants |
| Age, Categorical Between 18 and 65 years | 146 Participants | 151 Participants | 297 Participants |
| Age, Continuous | 66.87 years STANDARD_DEVIATION 9.42 | 66.35 years STANDARD_DEVIATION 9.16 | 66.6 years STANDARD_DEVIATION 9.28 |
| Sex: Female, Male Female | 193 Participants | 187 Participants | 380 Participants |
| Sex: Female, Male Male | 127 Participants | 133 Participants | 260 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 320 | 0 / 320 |
| serious Total, serious adverse events | 0 / 320 | 0 / 320 |
Outcome results
Primary
Total Blood Loss
The amount of blood lost during surgery is the primary outcome measure. Blood loss is determineusing an equation that calculates the patient's blood volume based on their height and weight, then multiplies the patient's blood volume by the change in their hematocrit after surgery compared to before surgery.
Time frame: during surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Topical Tranexamic Acid | Total Blood Loss | 323.59 ml | Standard Deviation 255.89 |
| Intravenous Tranexamic Acid | Total Blood Loss | 271.22 ml | Standard Deviation 212.06 |
Secondary
Drain Output
The amount of blood collected by a drain attached to the knee is measured 24 hours after surgery.
Time frame: from end of surgery to 24 hours postoperatively
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Topical Tranexamic Acid | Drain Output | 560.13 ml | Standard Deviation 297.21 |
| Intravenous Tranexamic Acid | Drain Output | 456.22 ml | Standard Deviation 275.39 |
Secondary
The Number Patients Requiring a Transfusion
TThe number Patients requiring a transfusion over the course of the patient's hospital stay.
Time frame: over course of hospital stay (averaging three days)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Topical Tranexamic Acid | The Number Patients Requiring a Transfusion | 2 Participants |
| Intravenous Tranexamic Acid | The Number Patients Requiring a Transfusion | 6 Participants |