Intraoperative Bleeding, Osteoarthritis
Conditions
Keywords
Blood loss, transfusion rates, complications
Brief summary
Hypotheses: Primary - A weighted dose of 20 mg/kg of tranexamic acid will be more efficacious than a single uniform dose of 1 gram in primary total knee arthroplasty (TKA) cases. This includes having a greater impact on decreasing blood loss without increasing the occurrence of adverse thromboembolic events in patients undergoing primary, elective total knee arthroplasty. Secondary - TA will decrease blood loss more effectively in women than in men undergoing this procedure.
Detailed description
Overall Study Design Study design and control methods: This study is designed as a prospective, randomized, double-blinded controlled clinical trial to compare the effect of a single uniform 1 g dose of TA and a single weighted 20 mg/kg dose of tranexamic acid (TA). Treatment group: The subjects will be randomly assigned to the uniform dose group or weighted dose group at the time of the surgery via the opening of a randomly selected closed envelope. The patient and the independent reviewer will be blinded as to the dose of TA utilized during the surgery. This information will be linked to a confidential database for later review by the principal investigator. Treatment allocation: All eligible patients (i.e., meeting inclusion criteria and no exclusion criteria) will be treated and observed per the research protocol. All patients will maintain the right to refuse participation and receive a specific treatment of the study if desired. Trial Population Target population: The target sample size is 60 patients of each of the uniform and weighted dose groups (120 total). There will be one actively enrolling surgeon (Dr. Brett Levine). The goal is to enroll a total of 120 subjects experiencing joint pain that warrants a TKA. The specific diagnosis for the joint pain will not direct the subjects' assignment or eligibility at the time of surgery. All 120 patients will be enrolled from the office of the primary investigator (Dr. Brett Levine). All indications for TKA will be included unless one of the exclusion criteria is met. Results from randomized patients will be compared to a historical control arm that did not receive TA in their treatment.
Interventions
DRUGTranexamic Acid standard dose
Uniform 1 gram dosing
DRUGFemales Tranexamic Acid weighted dose
Weighted dose--20mg/kg of the drug will be given
DRUGFemales receiving a uniform dose of TA
Patients will receive a uniform 1 gm dose of tranexamic acid prior to tourniquet release during a primary TKA.
DRUGMales Weighted Dose TA
Weighted dose--20mg/kg of the drug will be given
Sponsors
Rush University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
1. Patients must be male or female of any race 2. Ages 18-80 years old 3. Patients must be undergoing an elective, primary knee arthroplasty 4. Patients must be able to understand and willing to cooperate with study procedures 5. Patients must be able to provide written and verbal informed consent
Exclusion criteria
1. Allergy or intolerance to the study materials 2. History of a venous thromboembolic event being treated with life-long anticoagulation 3. Patients with a known congenital thrombophilia 4. Patients who have had a venous thromboembolic event within the 12 months preceding surgery 5. History of any substance abuse or dependence within the last 6 months 6. Failure in collecting a required data point during study 7. Those patients not indicated for knee replacement surgery including, pregnant women, those not cleared medically for the procedure and patients without significant radiographic evidence of degenerative joint disease. 8. Patient using autologous blood transfusion
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Intra-operative Blood Loss | Intra-operative, an average of 3 hours | Record intra-operative blood loss through drain output |
| Document Incidences of DVT and Other Thromboembolic Events. | 1 year | DVT = Deep Venous thrombosis Patients were assessed every 12 hours for development of pain within the lower extremity. Any reported muscle pain was evaluate with a bedside venous ultrasound by an ultrasound technician. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Female Patients Receiving a Uniform Dose of TA Female Patients receiving a single dose of 1 gram of TA--includes all patients that will get 1 gram dose of the TA during surgery. Postop outcomes will be measured for comparison, including hemoglobin, hematocrits and blood loss.
Patients will receive a uniform 1 gm dose of tranexamic acid prior to tourniquet release during a primary TKA. | 13 |
| Female Weighted Dose of TA Patients Female Patients receiving a weighted dose of TA. Will include all patients that will get a weighted dose of the TA during surgery. Postop outcomes will be measured for comparison, including hemoglobin, hematocrits and blood loss.
Tranexamic Acid weighted dose: Weighted dose--20mg/kg of the drug will be given | 12 |
| Control Historical cohort of primary TKAs performed by senior author, none of which received TA. | 25 |
| Male Patients Receiving a Uniform Dose of TA Male Patients receiving a single dose of 1 gram of TA--includes all patients that will get 1 gram dose of the TA during surgery. Postop outcomes will be measured for comparison, including hemoglobin, hematocrits and blood loss.
Patients will receive a uniform 1 gm dose of tranexamic acid prior to tourniquet release during a primary TKA. | 7 |
| Male Weighted Dose of TA Patients Male Patients receiving a weighted dose of TA. Will include all patients that will get a weighted dose of the TA during surgery. Postop outcomes will be measured for comparison, including hemoglobin, hematocrits and blood loss.
Tranexamic Acid weighted dose: Weighted dose--20mg/kg of the drug will be given | 8 |
| Total | 65 |
Baseline characteristics
| Characteristic | Female Patients Receiving a Uniform Dose of TA | Female Weighted Dose of TA Patients | Control | Male Patients Receiving a Uniform Dose of TA | Male Weighted Dose of TA Patients | Total |
|---|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 5 Participants | 7 Participants | 10 Participants | 3 Participants | 5 Participants | 30 Participants |
| Age, Categorical Between 18 and 65 years | 8 Participants | 5 Participants | 15 Participants | 4 Participants | 3 Participants | 35 Participants |
| Age, Continuous | 62.26 years STANDARD_DEVIATION 7.31 | 66.50 years STANDARD_DEVIATION 9.65 | 62.40 years STANDARD_DEVIATION 10.1 | 62.26 years STANDARD_DEVIATION 7.31 | 66.50 years STANDARD_DEVIATION 9.65 | 64.38 years STANDARD_DEVIATION 8.84 |
| ASA | 2.53 Scores on a Scale STANDARD_DEVIATION 0.6 | 2.26 Scores on a Scale STANDARD_DEVIATION 0.7 | 2.57 Scores on a Scale STANDARD_DEVIATION 0.5 | 2.53 Scores on a Scale STANDARD_DEVIATION 0.6 | 2.26 Scores on a Scale STANDARD_DEVIATION 0.7 | 2.395 Scores on a Scale STANDARD_DEVIATION 0.67 |
| BMI | 32.10 kg/m^2 STANDARD_DEVIATION 8.04 | 35.40 kg/m^2 STANDARD_DEVIATION 8.5 | 36 kg/m^2 STANDARD_DEVIATION 11.09 | 32.10 kg/m^2 STANDARD_DEVIATION 8.04 | 35.40 kg/m^2 STANDARD_DEVIATION 8.5 | 33.75 kg/m^2 STANDARD_DEVIATION 8.436 |
| Sex: Female, Male Female | 13 Participants | 12 Participants | 15 Participants | 0 Participants | 0 Participants | 40 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 10 Participants | 7 Participants | 8 Participants | 25 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 13 | 1 / 12 | 10 / 25 | 0 / 7 | 0 / 8 |
| serious Total, serious adverse events | 1 / 13 | 1 / 12 | 0 / 25 | 0 / 7 | 0 / 8 |
Outcome results
Primary
Document Incidences of DVT and Other Thromboembolic Events.
DVT = Deep Venous thrombosis Patients were assessed every 12 hours for development of pain within the lower extremity. Any reported muscle pain was evaluate with a bedside venous ultrasound by an ultrasound technician.
Time frame: 1 year
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Female Uniform Single Dose TA Patient | Document Incidences of DVT and Other Thromboembolic Events. | 1 Events |
| Female Weighted Dose TA Patient | Document Incidences of DVT and Other Thromboembolic Events. | 1 Events |
| Control | Document Incidences of DVT and Other Thromboembolic Events. | 0 Events |
| Male Uniform Single Dose TA | Document Incidences of DVT and Other Thromboembolic Events. | 0 Events |
| Male Weighted Dose TA Patient | Document Incidences of DVT and Other Thromboembolic Events. | 0 Events |
Primary
Primary Intra-operative Blood Loss
Record intra-operative blood loss through drain output
Time frame: Intra-operative, an average of 3 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Female Uniform Single Dose TA Patient | Primary Intra-operative Blood Loss | 100.00 mL | Standard Deviation 31.69 |
| Female Weighted Dose TA Patient | Primary Intra-operative Blood Loss | 65.00 mL | Standard Deviation 8.5 |
| Control | Primary Intra-operative Blood Loss | 142.80 mL | Standard Deviation 197 |
| Male Uniform Single Dose TA | Primary Intra-operative Blood Loss | 100.00 mL | Standard Deviation 31.69 |
| Male Weighted Dose TA Patient | Primary Intra-operative Blood Loss | 65.00 mL | Standard Deviation 8.5 |