Hip Arthropathy, Osteoarthritis, Shoulder Arthropathy
Conditions
Keywords
tranexamic acid (TXA)
Brief summary
The objective of this study is to evaluate the efficacy of topical tranexamic acid (TXA) in decreasing blood loss following both shoulder arthroplasty and primary total hip arthroplasty. TXA functions to decrease blood loss by affecting the blood clotting system within the body. The investigators hypothesize that topical application of TXA prior to closure reduces postoperative bleeding as measured by absolute changes in postoperative hemoglobin levels and surgical drain output. In addition, use of topically applied tranexamic acid may reduce the need for transfusions, the rates of hematomas, infections, and length of hospital stay.
Interventions
BIOLOGICALTranexamic acid (TXA)
1.5g of TXA in 100ml normal saline solution
DRUGNormal saline
Sponsors
The Hawkins Foundation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Shoulders: All adult patients over the age of 18 scheduled for a primary total arthroplasty or a primary reverse shoulder arthroplasty will be eligible for inclusion in the study. Hips: All adult patients over the age of 18 scheduled for a primary total hip arthroplasty will be eligible for inclusion in the study.
Exclusion criteria
* allergy to TXA, refusal of blood products, preoperative use of anticoagulant therapy within 5 days of surgery, history of seizures, renal failure (creatine clearance \<30ml/min), bleeding disorders, venous thromboembolism (deep vein thrombosis and/or pulmonary embolism), significant cardiac history (myocardial infarction, angina, stroke, lower limb ischemia), or perioperative anemia (hemoglobin \<11g/dl in females and \< 12g/dl in males).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Post-operative Blood Loss | Duration of hospital stay, up to 4 days | Blood loss will be calculated as the difference between the preoperative hemoglobin and the lowest postoperative hemoglobin during the hospital stay or the lowest postoperative hemoglobin prior to blood transfusion. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Blood Units Transfused | Duration of hospital stay, up to 4 days | — |
| Rate of Surgical Infections | Duration of hospital stay, up to 4 days | — |
| Number of Participants With Perioperative Blood Transfusions | Duration of hospital stay, up to 4 days | — |
| Patient-reported Outcomes Scores, Including Euroqol-5D (EQ-5D), Global Rating of Change Scale (GRoC), and Single Alpha Numeric Evaluation (SANE). | 6 months post-surgery | * Single Assessment Numeric Evaluation (SANE): A single question that asks How would you rate your hip today as a percentage of normal (0% to 100% scale with 100% being normal)? 0 indicates an abnormal shoulder, whereas 100% indicates a perfectly normal shoulder. * Euroqol-5D (EQ-5D): The EQ-5D is a patient-reported overall health questionnaire, with 100 indicating The best health you can imagine and 0 indicating The worst health you can imagine. * Global Rating of Change Scale (GRoC): Provide a means of measuring self-perceived change in health status. The main purpose is to quantify the extent to which a patient has improved or deteriorated over time. The outcome is measured on a scale of -7 to 7, with -7 being the hip is a very great deal worse from before surgery and 7 being the hip is a very great deal better from before surgery. |
| Patient-reported Outcome Scores Including the Harris Hip Score and Western Ontario and McMaster Universities Arthritis Index (WOMAC) | 6 months after surgery | Harris Hip Score: Consists of 10 question items evaluating pain, function, absence of deformity, and range of motion. Scores range from 0-100 with higher scores representing less dysfunction and better outcomes, whereas lower scores represent more dysfunction and worse outcomes. Western Ontario and McMaster Universities Arthritis Index (WOMAC): Consists of 24 questions evaluating hip pain, stiffness and function. The score is normalized to a 100 point scale, where 0 indicates a poor outcome and 100 indicates the best outcome. |
| Length of Hospital Stay | Duration of hospital stay | — |
Countries
United States
Participant flow
Recruitment details
122 patients were enrolled and randomized into one of two groups: tranexamic acid administered topically and saline administered topically (control). 61 patients were enrolled in each of the two groups. In addition, 66 patients who received tranexamic acid intravenously were retrospectively analyzed as a comparative group.
Participants by arm
| Arm | Count |
|---|---|
| Topical Tranexamic Acid (TXA) TXA administered topically
Tranexamic acid (TXA): 1.5g of TXA in 100ml normal saline solution administered topically | 61 |
| Saline Normal saline administered topically | 61 |
| Intravenous Tranexamic Acid (TXA) Current standard of care is Tranexamic acid (TXA) administered intravenously. This arm was added as a retrospective comparative group, thus these patients were not randomized during the original study. | 66 |
| Total | 188 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Physician Decision | 3 | 3 | 0 |
| Overall Study | screen fail | 2 | 4 | 0 |
| Overall Study | Withdrawal by Subject | 6 | 4 | 0 |
Baseline characteristics
| Characteristic | Topical Tranexamic Acid (TXA) | Total | Intravenous Tranexamic Acid (TXA) | Saline |
|---|---|---|---|---|
| Age, Continuous | 62 years | 64.2 years | 65 years | 65 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 1 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 49 Participants | 165 Participants | 66 Participants | 50 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 5 Participants | 14 Participants | 5 Participants | 4 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 45 Participants | 152 Participants | 61 Participants | 46 Participants |
| Region of Enrollment United States | 50 Participants | 166 Participants | 66 Participants | 50 Participants |
| Sex: Female, Male Female | 29 Participants | 83 Participants | 31 Participants | 23 Participants |
| Sex: Female, Male Male | 21 Participants | 83 Participants | 35 Participants | 27 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 50 | 0 / 50 | 0 / 66 |
| other Total, other adverse events | 4 / 50 | 0 / 50 | 4 / 66 |
| serious Total, serious adverse events | 0 / 50 | 0 / 50 | 0 / 66 |
Outcome results
Primary
Post-operative Blood Loss
Blood loss will be calculated as the difference between the preoperative hemoglobin and the lowest postoperative hemoglobin during the hospital stay or the lowest postoperative hemoglobin prior to blood transfusion.
Time frame: Duration of hospital stay, up to 4 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Topical Tranexamic Acid (TXA) | Post-operative Blood Loss | 1,062.88 mL | Standard Deviation 338.78 |
| Saline | Post-operative Blood Loss | 1,204.60 mL | Standard Deviation 403.61 |
| Intravenous Tranexamic Acid (TXA) | Post-operative Blood Loss | 933.92 mL | Standard Deviation 351.17 |
Secondary
Length of Hospital Stay
Time frame: Duration of hospital stay
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Topical Tranexamic Acid (TXA) | Length of Hospital Stay | 1.52 days | Standard Deviation 0.61 |
| Saline | Length of Hospital Stay | 1.64 days | Standard Deviation 0.72 |
| Intravenous Tranexamic Acid (TXA) | Length of Hospital Stay | 1.39 days | Standard Deviation 0.63 |
Secondary
Number of Blood Units Transfused
Time frame: Duration of hospital stay, up to 4 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Topical Tranexamic Acid (TXA) | Number of Blood Units Transfused | 0 blood units |
| Saline | Number of Blood Units Transfused | 0 blood units |
| Intravenous Tranexamic Acid (TXA) | Number of Blood Units Transfused | 0 blood units |
Secondary
Number of Participants With Perioperative Blood Transfusions
Time frame: Duration of hospital stay, up to 4 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Topical Tranexamic Acid (TXA) | Number of Participants With Perioperative Blood Transfusions | 0 participants |
| Saline | Number of Participants With Perioperative Blood Transfusions | 0 participants |
| Intravenous Tranexamic Acid (TXA) | Number of Participants With Perioperative Blood Transfusions | 0 participants |
Secondary
Patient-reported Outcome Scores Including the Harris Hip Score and Western Ontario and McMaster Universities Arthritis Index (WOMAC)
Harris Hip Score: Consists of 10 question items evaluating pain, function, absence of deformity, and range of motion. Scores range from 0-100 with higher scores representing less dysfunction and better outcomes, whereas lower scores represent more dysfunction and worse outcomes. Western Ontario and McMaster Universities Arthritis Index (WOMAC): Consists of 24 questions evaluating hip pain, stiffness and function. The score is normalized to a 100 point scale, where 0 indicates a poor outcome and 100 indicates the best outcome.
Time frame: 6 months after surgery
Population: Patient-reported outcomes were only collected for the two randomized patient groups (Topical tranexamic acid and saline). Patient-reported outcomes were not collected on the intravenous tranexamic acid group, as this group was added for retrospective comparison.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Topical Tranexamic Acid (TXA) | Patient-reported Outcome Scores Including the Harris Hip Score and Western Ontario and McMaster Universities Arthritis Index (WOMAC) | Harris Hip Score | 85.03 score on a scale | Standard Deviation 15.9 |
| Topical Tranexamic Acid (TXA) | Patient-reported Outcome Scores Including the Harris Hip Score and Western Ontario and McMaster Universities Arthritis Index (WOMAC) | WOMAC | 14.64 score on a scale | Standard Deviation 15.42 |
| Saline | Patient-reported Outcome Scores Including the Harris Hip Score and Western Ontario and McMaster Universities Arthritis Index (WOMAC) | Harris Hip Score | 79.95 score on a scale | Standard Deviation 18.5 |
| Saline | Patient-reported Outcome Scores Including the Harris Hip Score and Western Ontario and McMaster Universities Arthritis Index (WOMAC) | WOMAC | 13.46 score on a scale | Standard Deviation 11.23 |
Secondary
Patient-reported Outcomes Scores, Including Euroqol-5D (EQ-5D), Global Rating of Change Scale (GRoC), and Single Alpha Numeric Evaluation (SANE).
* Single Assessment Numeric Evaluation (SANE): A single question that asks How would you rate your hip today as a percentage of normal (0% to 100% scale with 100% being normal)? 0 indicates an abnormal shoulder, whereas 100% indicates a perfectly normal shoulder. * Euroqol-5D (EQ-5D): The EQ-5D is a patient-reported overall health questionnaire, with 100 indicating The best health you can imagine and 0 indicating The worst health you can imagine. * Global Rating of Change Scale (GRoC): Provide a means of measuring self-perceived change in health status. The main purpose is to quantify the extent to which a patient has improved or deteriorated over time. The outcome is measured on a scale of -7 to 7, with -7 being the hip is a very great deal worse from before surgery and 7 being the hip is a very great deal better from before surgery.
Time frame: 6 months post-surgery
Population: Patient-reported outcomes were only collected for the two randomized patient groups (Topical tranexamic acid and saline). Patient-reported outcomes were not collected on the intravenous tranexamic acid group, as this group was added for retrospective comparison.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Topical Tranexamic Acid (TXA) | Patient-reported Outcomes Scores, Including Euroqol-5D (EQ-5D), Global Rating of Change Scale (GRoC), and Single Alpha Numeric Evaluation (SANE). | EQ-5D | 84.87 score on a scale | Standard Deviation 13.69 |
| Topical Tranexamic Acid (TXA) | Patient-reported Outcomes Scores, Including Euroqol-5D (EQ-5D), Global Rating of Change Scale (GRoC), and Single Alpha Numeric Evaluation (SANE). | GRoC | 6.24 score on a scale | Standard Deviation 0.91 |
| Topical Tranexamic Acid (TXA) | Patient-reported Outcomes Scores, Including Euroqol-5D (EQ-5D), Global Rating of Change Scale (GRoC), and Single Alpha Numeric Evaluation (SANE). | SANE | 89.06 score on a scale | Standard Deviation 8.51 |
| Saline | Patient-reported Outcomes Scores, Including Euroqol-5D (EQ-5D), Global Rating of Change Scale (GRoC), and Single Alpha Numeric Evaluation (SANE). | EQ-5D | 80.15 score on a scale | Standard Deviation 16.58 |
| Saline | Patient-reported Outcomes Scores, Including Euroqol-5D (EQ-5D), Global Rating of Change Scale (GRoC), and Single Alpha Numeric Evaluation (SANE). | GRoC | 5.54 score on a scale | Standard Deviation 2.03 |
| Saline | Patient-reported Outcomes Scores, Including Euroqol-5D (EQ-5D), Global Rating of Change Scale (GRoC), and Single Alpha Numeric Evaluation (SANE). | SANE | 81.08 score on a scale | Standard Deviation 21.61 |
Secondary
Rate of Surgical Infections
Time frame: Duration of hospital stay, up to 4 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Topical Tranexamic Acid (TXA) | Rate of Surgical Infections | 0 Participants |
| Saline | Rate of Surgical Infections | 0 Participants |
| Intravenous Tranexamic Acid (TXA) | Rate of Surgical Infections | 0 Participants |