A Phase 4 interventional study of Tranexamic acid (TXA) and Normal saline in Osteoarthritis, Hip Arthropathy and Shoulder Arthropathy, sponsored by The Hawkins Foundation. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-05-05.
Sponsored by The Hawkins Foundation · Phase 4, Interventional, and Treatment
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.
712 studies on the registry are indexed under Joint Diseases; 127 are open to participants now.
This study's enrollment of 188 is above the median of 60 across 470 interventional studies indexed under Joint Diseases.
Browse Joint Diseases studies →The Hawkins Foundation is the lead sponsor of 13 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
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:
Tranexamic acid (TXA) applied topically
Biological: Tranexamic acid (TXA)
Normal saline
Drug: Normal saline
Tranexamic acid (TXA) administered intravenously
Biological: Tranexamic acid (TXA)
1.5g of TXA in 100ml normal saline solution
Also known as: Cyklokapron
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
Number of Participants With Perioperative Blood Transfusions
Time frame: Duration of hospital stay, up to 4 days
Number of Blood Units Transfused
Time frame: Duration of hospital stay, up to 4 days
Rate of Surgical Infections
Time frame: Duration of hospital stay, up to 4 days
Length of Hospital Stay
Time frame: Duration of hospital stay
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
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
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.
| Milestone | Topical Tranexamic Acid (TXA) | Saline (Control) | Intravenous Tranexamic Acid (TXA) |
|---|---|---|---|
| Started | 61 | 61 | 66 |
| Completed | 50 | 50 | 66 |
| Not completed | 11 | 11 | 0 |
| Withdrew: Physician decision | 3 | 3 | 0 |
| Withdrew: Withdrawal by subject | 6 | 4 | 0 |
| Withdrew: Screen fail | 2 | 4 | 0 |
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.
| mL | Topical Tranexamic Acid (TXA) | Saline | Intravenous Tranexamic Acid (TXA) |
|---|---|---|---|
| Post-operative Blood Loss | 1,062.88 ± 338.78 | 1,204.60 ± 403.61 | 933.92 ± 351.17 |
| participants | Topical Tranexamic Acid (TXA) | Saline | Intravenous Tranexamic Acid (TXA) |
|---|---|---|---|
| Number of Participants With Perioperative Blood Transfusions | 0 | 0 | 0 |
| blood units | Topical Tranexamic Acid (TXA) | Saline | Intravenous Tranexamic Acid (TXA) |
|---|---|---|---|
| Number of Blood Units Transfused | 0 | 0 | 0 |
| Participants | Topical Tranexamic Acid (TXA) | Saline | Intravenous Tranexamic Acid (TXA) |
|---|---|---|---|
| Rate of Surgical Infections | 0 | 0 | 0 |
| days | Topical Tranexamic Acid (TXA) | Saline | Intravenous Tranexamic Acid (TXA) |
|---|---|---|---|
| Length of Hospital Stay | 1.52 ± 0.61 | 1.64 ± 0.72 | 1.39 ± 0.63 |
* 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."
| score on a scale | Topical Tranexamic Acid (TXA) | Saline |
|---|---|---|
| EQ-5D | 84.87 ± 13.69 | 80.15 ± 16.58 |
| GRoC | 6.24 ± 0.91 | 5.54 ± 2.03 |
| SANE | 89.06 ± 8.51 | 81.08 ± 21.61 |
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.
| score on a scale | Topical Tranexamic Acid (TXA) | Saline |
|---|---|---|
| Harris Hip Score | 85.03 ± 15.90 | 79.95 ± 18.5 |
| WOMAC | 14.64 ± 15.42 | 13.46 ± 11.23 |
Collected over Adverse events were collected from date of surgery to 6 month follow-up. All adverse events from the date of surgery to the final 6 month follow-up were assessed and collected for each patient.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Topical Tranexamic Acid (TXA) | 0/50 (0%) | 0/50 (0%) | 4/50 (8%) |
| Saline | 0/50 (0%) | 0/50 (0%) | 0/50 (0%) |
| Intravenous Tranexamic Acid (TXA) | 0/66 (0%) | 0/66 (0%) | 4/66 (6.1%) |
| Event | Topical Tranexamic Acid (TXA) | Saline | Intravenous Tranexamic Acid (TXA) |
|---|---|---|---|
| hematomaVascular disorders | 2/50 | 0/50 | 1/66 |
| deep vein thrombosisVascular disorders | 1/50 | 0/50 | 2/66 |
| ischemic strokeVascular disorders | 1/50 | 0/50 | 0/66 |
| AneurysmVascular disorders | 0/50 | 0/50 | 1/66 |
| Age, Continuous(years) | Topical Tranexamic Acid (TXA) | Saline | Intravenous Tranexamic Acid (TXA) | Total |
|---|---|---|---|---|
| Mean | 62 (35 to 86) | 65 (40 to 87) | 65 (35 to 83) | 64.2 (35 to 87) |
| Sex: Female, Male(Participants) | Topical Tranexamic Acid (TXA) | Saline | Intravenous Tranexamic Acid (TXA) | Total |
|---|---|---|---|---|
| Female | 29 | 23 | 31 | 83 |
| Male | 21 | 27 | 35 | 83 |
| Ethnicity (NIH/OMB)(Participants) | Topical Tranexamic Acid (TXA) | Saline | Intravenous Tranexamic Acid (TXA) | Total |
|---|---|---|---|---|
| Hispanic or Latino | 1 | 0 | 0 | 1 |
| Not Hispanic or Latino | 49 | 50 | 66 | 165 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Topical Tranexamic Acid (TXA) | Saline | Intravenous Tranexamic Acid (TXA) | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 |
| Black or African American | 5 | 4 | 5 | 14 |
| White | 45 | 46 | 61 | 152 |
| More than one race | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 |
| Region of Enrollment(Participants) | Topical Tranexamic Acid (TXA) | Saline | Intravenous Tranexamic Acid (TXA) | Total |
|---|---|---|---|---|
| United States | 50 | 50 | 66 | 166 |
Documents are hosted by the registry — open the source record to download them.
This study is completed, as verified in Apr 2020. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
The Hawkins Foundation