Trial Outcomes & Findings for Topical Tranexamic Acid (TXA) in Joint Arthroplasty (NCT NCT01937559)

NCT ID: NCT01937559

Last Updated: 2020-05-05

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

188 participants

Primary outcome timeframe

Duration of hospital stay, up to 4 days

Results posted on

2020-05-05

Participant Flow

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.

Participant milestones

Participant milestones
Measure	Topical Tranexamic Acid (TXA) Tranexamic acid (TXA): 1.5g of TXA in 100ml normal saline solution administered topically	Saline (Control) Normal saline administered topically (control)	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.
Overall Study STARTED	61	61	66
Overall Study COMPLETED	50	50	66
Overall Study NOT COMPLETED	11	11	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Topical Tranexamic Acid (TXA) Tranexamic acid (TXA): 1.5g of TXA in 100ml normal saline solution administered topically	Saline (Control) Normal saline administered topically (control)
Overall Study Physician Decision	3	3
Overall Study Withdrawal by Subject	6	4
Overall Study screen fail	2	4

Baseline Characteristics

Several patients withdrew prior to primary endpoint being collected and thus were not included in analysis.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Topical Tranexamic Acid (TXA) n=61 Participants TXA administered topically Tranexamic acid (TXA): 1.5g of TXA in 100ml normal saline solution administered topically	Saline n=61 Participants Normal saline administered topically	Intravenous Tranexamic Acid (TXA) n=66 Participants 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.	Total n=188 Participants Total of all reporting groups
Age, Continuous	62 years n=50 Participants • Several patients withdrew prior to primary endpoint being collected and thus were not included in analysis.	65 years n=50 Participants • Several patients withdrew prior to primary endpoint being collected and thus were not included in analysis.	65 years n=66 Participants • Several patients withdrew prior to primary endpoint being collected and thus were not included in analysis.	64.2 years n=166 Participants • Several patients withdrew prior to primary endpoint being collected and thus were not included in analysis.
Sex: Female, Male Female	29 Participants n=50 Participants • Several patients withdrew prior to primary endpoint being collected and thus were not included in analysis.	23 Participants n=50 Participants • Several patients withdrew prior to primary endpoint being collected and thus were not included in analysis.	31 Participants n=66 Participants • Several patients withdrew prior to primary endpoint being collected and thus were not included in analysis.	83 Participants n=166 Participants • Several patients withdrew prior to primary endpoint being collected and thus were not included in analysis.
Sex: Female, Male Male	21 Participants n=50 Participants • Several patients withdrew prior to primary endpoint being collected and thus were not included in analysis.	27 Participants n=50 Participants • Several patients withdrew prior to primary endpoint being collected and thus were not included in analysis.	35 Participants n=66 Participants • Several patients withdrew prior to primary endpoint being collected and thus were not included in analysis.	83 Participants n=166 Participants • Several patients withdrew prior to primary endpoint being collected and thus were not included in analysis.
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=50 Participants • Several patients withdrew prior to primary endpoint being collected and thus were not included in analysis.	0 Participants n=50 Participants • Several patients withdrew prior to primary endpoint being collected and thus were not included in analysis.	0 Participants n=66 Participants • Several patients withdrew prior to primary endpoint being collected and thus were not included in analysis.	1 Participants n=166 Participants • Several patients withdrew prior to primary endpoint being collected and thus were not included in analysis.
Ethnicity (NIH/OMB) Not Hispanic or Latino	49 Participants n=50 Participants • Several patients withdrew prior to primary endpoint being collected and thus were not included in analysis.	50 Participants n=50 Participants • Several patients withdrew prior to primary endpoint being collected and thus were not included in analysis.	66 Participants n=66 Participants • Several patients withdrew prior to primary endpoint being collected and thus were not included in analysis.	165 Participants n=166 Participants • Several patients withdrew prior to primary endpoint being collected and thus were not included in analysis.
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=50 Participants • Several patients withdrew prior to primary endpoint being collected and thus were not included in analysis.	0 Participants n=50 Participants • Several patients withdrew prior to primary endpoint being collected and thus were not included in analysis.	0 Participants n=66 Participants • Several patients withdrew prior to primary endpoint being collected and thus were not included in analysis.	0 Participants n=166 Participants • Several patients withdrew prior to primary endpoint being collected and thus were not included in analysis.
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=50 Participants • Several patients withdrew prior to primary endpoint being collected and thus were not included in analysis.	0 Participants n=50 Participants • Several patients withdrew prior to primary endpoint being collected and thus were not included in analysis.	0 Participants n=66 Participants • Several patients withdrew prior to primary endpoint being collected and thus were not included in analysis.	0 Participants n=166 Participants • Several patients withdrew prior to primary endpoint being collected and thus were not included in analysis.
Race (NIH/OMB) Asian	0 Participants n=50 Participants • Several patients withdrew prior to primary endpoint being collected and thus were not included in analysis.	0 Participants n=50 Participants • Several patients withdrew prior to primary endpoint being collected and thus were not included in analysis.	0 Participants n=66 Participants • Several patients withdrew prior to primary endpoint being collected and thus were not included in analysis.	0 Participants n=166 Participants • Several patients withdrew prior to primary endpoint being collected and thus were not included in analysis.
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=50 Participants • Several patients withdrew prior to primary endpoint being collected and thus were not included in analysis.	0 Participants n=50 Participants • Several patients withdrew prior to primary endpoint being collected and thus were not included in analysis.	0 Participants n=66 Participants • Several patients withdrew prior to primary endpoint being collected and thus were not included in analysis.	0 Participants n=166 Participants • Several patients withdrew prior to primary endpoint being collected and thus were not included in analysis.
Race (NIH/OMB) Black or African American	5 Participants n=50 Participants • Several patients withdrew prior to primary endpoint being collected and thus were not included in analysis.	4 Participants n=50 Participants • Several patients withdrew prior to primary endpoint being collected and thus were not included in analysis.	5 Participants n=66 Participants • Several patients withdrew prior to primary endpoint being collected and thus were not included in analysis.	14 Participants n=166 Participants • Several patients withdrew prior to primary endpoint being collected and thus were not included in analysis.
Race (NIH/OMB) White	45 Participants n=50 Participants • Several patients withdrew prior to primary endpoint being collected and thus were not included in analysis.	46 Participants n=50 Participants • Several patients withdrew prior to primary endpoint being collected and thus were not included in analysis.	61 Participants n=66 Participants • Several patients withdrew prior to primary endpoint being collected and thus were not included in analysis.	152 Participants n=166 Participants • Several patients withdrew prior to primary endpoint being collected and thus were not included in analysis.
Race (NIH/OMB) More than one race	0 Participants n=50 Participants • Several patients withdrew prior to primary endpoint being collected and thus were not included in analysis.	0 Participants n=50 Participants • Several patients withdrew prior to primary endpoint being collected and thus were not included in analysis.	0 Participants n=66 Participants • Several patients withdrew prior to primary endpoint being collected and thus were not included in analysis.	0 Participants n=166 Participants • Several patients withdrew prior to primary endpoint being collected and thus were not included in analysis.
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=50 Participants • Several patients withdrew prior to primary endpoint being collected and thus were not included in analysis.	0 Participants n=50 Participants • Several patients withdrew prior to primary endpoint being collected and thus were not included in analysis.	0 Participants n=66 Participants • Several patients withdrew prior to primary endpoint being collected and thus were not included in analysis.	0 Participants n=166 Participants • Several patients withdrew prior to primary endpoint being collected and thus were not included in analysis.
Region of Enrollment United States	50 Participants n=50 Participants • 22 patients were withdrawn prior to surgery (11 in the Topical tranexamic acid group and 11 in the saline group). These patients were not included in the analysis population due to their pre-operative withdrawal from the study.	50 Participants n=50 Participants • 22 patients were withdrawn prior to surgery (11 in the Topical tranexamic acid group and 11 in the saline group). These patients were not included in the analysis population due to their pre-operative withdrawal from the study.	66 Participants n=66 Participants • 22 patients were withdrawn prior to surgery (11 in the Topical tranexamic acid group and 11 in the saline group). These patients were not included in the analysis population due to their pre-operative withdrawal from the study.	166 Participants n=166 Participants • 22 patients were withdrawn prior to surgery (11 in the Topical tranexamic acid group and 11 in the saline group). These patients were not included in the analysis population due to their pre-operative withdrawal from the study.

PRIMARY outcome

Timeframe: Duration of hospital stay, up to 4 days

Outcome measures

Outcome measures
Measure	Topical Tranexamic Acid (TXA) n=50 Participants Tranexamic acid (TXA) administered topically Tranexamic acid (TXA): 1.5g of TXA in 100ml normal saline solution	Saline n=50 Participants Normal saline Normal saline	Intravenous Tranexamic Acid (TXA) n=66 Participants Tranexamic acid (TXA) administered intravenously
Post-operative Blood Loss	1,062.88 mL Standard Deviation 338.78	1,204.60 mL Standard Deviation 403.61	933.92 mL Standard Deviation 351.17

SECONDARY outcome

Timeframe: Duration of hospital stay, up to 4 days

Outcome measures

Outcome measures
Measure	Topical Tranexamic Acid (TXA) n=50 Participants Tranexamic acid (TXA) administered topically Tranexamic acid (TXA): 1.5g of TXA in 100ml normal saline solution	Saline n=50 Participants Normal saline Normal saline	Intravenous Tranexamic Acid (TXA) n=66 Participants Tranexamic acid (TXA) administered intravenously
Number of Participants With Perioperative Blood Transfusions	0 participants	0 participants	0 participants

SECONDARY outcome

Timeframe: Duration of hospital stay, up to 4 days

Outcome measures

Outcome measures
Measure	Topical Tranexamic Acid (TXA) n=50 Participants Tranexamic acid (TXA) administered topically Tranexamic acid (TXA): 1.5g of TXA in 100ml normal saline solution	Saline n=50 Participants Normal saline Normal saline	Intravenous Tranexamic Acid (TXA) n=66 Participants Tranexamic acid (TXA) administered intravenously
Number of Blood Units Transfused	0 blood units	0 blood units	0 blood units

SECONDARY outcome

Timeframe: Duration of hospital stay, up to 4 days

Outcome measures

Outcome measures
Measure	Topical Tranexamic Acid (TXA) n=50 Participants Tranexamic acid (TXA) administered topically Tranexamic acid (TXA): 1.5g of TXA in 100ml normal saline solution	Saline n=50 Participants Normal saline Normal saline	Intravenous Tranexamic Acid (TXA) n=66 Participants Tranexamic acid (TXA) administered intravenously
Rate of Surgical Infections	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Duration of hospital stay

Outcome measures

Outcome measures
Measure	Topical Tranexamic Acid (TXA) n=50 Participants Tranexamic acid (TXA) administered topically Tranexamic acid (TXA): 1.5g of TXA in 100ml normal saline solution	Saline n=50 Participants Normal saline Normal saline	Intravenous Tranexamic Acid (TXA) n=66 Participants Tranexamic acid (TXA) administered intravenously
Length of Hospital Stay	1.52 days Standard Deviation 0.61	1.64 days Standard Deviation 0.72	1.39 days Standard Deviation 0.63

SECONDARY outcome

Timeframe: 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.

* 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."

Outcome measures

Outcome measures
Measure	Topical Tranexamic Acid (TXA) n=50 Participants Tranexamic acid (TXA) administered topically Tranexamic acid (TXA): 1.5g of TXA in 100ml normal saline solution	Saline n=50 Participants Normal saline Normal saline	Intravenous Tranexamic Acid (TXA) Tranexamic acid (TXA) administered intravenously
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	80.15 score on a scale Standard Deviation 16.58	—
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	5.54 score on a scale Standard Deviation 2.03	—
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	81.08 score on a scale Standard Deviation 21.61	—

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Topical Tranexamic Acid (TXA) n=50 Participants Tranexamic acid (TXA) administered topically Tranexamic acid (TXA): 1.5g of TXA in 100ml normal saline solution	Saline n=50 Participants Normal saline Normal saline	Intravenous Tranexamic Acid (TXA) Tranexamic acid (TXA) administered intravenously
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 15.90	79.95 score on a scale Standard Deviation 18.5	—
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	13.46 score on a scale Standard Deviation 11.23	—

Adverse Events

Topical Tranexamic Acid (TXA)

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Saline

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Intravenous Tranexamic Acid (TXA)

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Topical Tranexamic Acid (TXA) n=50 participants at risk Topical Tranexamic acid (TXA) Tranexamic acid (TXA): 1.5g of TXA in 100ml normal saline solution	Saline n=50 participants at risk Normal saline Normal saline	Intravenous Tranexamic Acid (TXA) n=66 participants at risk Intravenous Tranexamic acid (TXA)
Vascular disorders ischemic stroke	2.0% 1/50 • Number of events 1 • 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.	0.00% 0/50 • 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.	0.00% 0/66 • 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.
Vascular disorders hematoma	4.0% 2/50 • Number of events 2 • 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.	0.00% 0/50 • 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.	1.5% 1/66 • Number of events 1 • 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.
Vascular disorders deep vein thrombosis	2.0% 1/50 • Number of events 1 • 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.	0.00% 0/50 • 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.	3.0% 2/66 • Number of events 2 • 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.
Vascular disorders Aneurysm	0.00% 0/50 • 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.	0.00% 0/50 • 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.	1.5% 1/66 • Number of events 1 • 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.

Additional Information

Kyle Adams, Research Coordinator

Hawkins Foundation

Phone: 864-454-7458

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place