Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Topical Tranexamic acid (TXA) | Experimental | Tranexamic acid (TXA) applied topically |
|
| Saline | Placebo Comparator | Normal saline |
|
| Tranexamic acid (TXA) | Active Comparator | Tranexamic acid (TXA) administered intravenously |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tranexamic acid (TXA) | Biological | 1.5g of TXA in 100ml normal saline solution |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Duration of hospital stay, up to 4 days |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Perioperative Blood Transfusions | Duration of hospital stay, up to 4 days | |
| Number of Blood Units Transfused | Duration of hospital stay, up to 4 days | |
Not provided
Inclusion Criteria:
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:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Brian Burnikel, MD | Steadman Hawkins Clinic of the Carolinas - Greenville Health System | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Steadman Hawkins Clinic of the Carolinas - Greenville Health System | Greenville | South Carolina | 29615 | United States |
Not provided
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.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Topical Tranexamic Acid (TXA) | Tranexamic acid (TXA): 1.5g of TXA in 100ml normal saline solution administered topically |
| FG001 | Saline (Control) | Normal saline administered topically (control) |
| FG002 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Topical Tranexamic Acid (TXA) | TXA administered topically Tranexamic acid (TXA): 1.5g of TXA in 100ml normal saline solution administered topically |
| BG001 | Saline | Normal saline administered topically |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Several patients withdrew prior to primary endpoint being collected and thus were not included in analysis. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Deviation | mL | Duration of hospital stay, up to 4 days |
|
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.
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Topical Tranexamic Acid (TXA) | Topical Tranexamic acid (TXA) Tranexamic acid (TXA): 1.5g of TXA in 100ml normal saline solution |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ischemic stroke | Vascular disorders | Non-systematic Assessment | ischemic stroke reported 8 months after surgery |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kyle Adams, Research Coordinator | Hawkins Foundation | 864-454-7458 | kyle.adams@hawkinsfoundation.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 8, 2018 | Apr 10, 2020 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D014148 | Tranexamic Acid |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D003509 | Cyclohexanecarboxylic Acids |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Normal saline | Drug |
|
| Rate of Surgical Infections |
| Duration of hospital stay, up to 4 days |
| Length of Hospital Stay | 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). |
| 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. | 6 months after surgery |
| screen fail |
|
| BG002 | 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. |
| BG003 | Total | Total of all reporting groups |
| Mean |
| Full Range |
| years |
|
| Sex: Female, Male | Several patients withdrew prior to primary endpoint being collected and thus were not included in analysis. | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Several patients withdrew prior to primary endpoint being collected and thus were not included in analysis. | Count of Participants | Participants |
|
| Race (NIH/OMB) | Several patients withdrew prior to primary endpoint being collected and thus were not included in analysis. | Count of Participants | Participants |
|
| Region of Enrollment | 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. | Count of Participants | Participants |
|
Tranexamic acid (TXA) administered intravenously |
|
|
| Secondary | Number of Participants With Perioperative Blood Transfusions | Posted | Number | participants | Duration of hospital stay, up to 4 days |
|
|
|
| Secondary | Number of Blood Units Transfused | Posted | Number | blood units | Duration of hospital stay, up to 4 days |
|
|
|
| Secondary | Rate of Surgical Infections | Posted | Count of Participants | Participants | Duration of hospital stay, up to 4 days |
|
|
|
| Secondary | Length of Hospital Stay | Posted | Mean | Standard Deviation | days | Duration of hospital stay |
|
|
|
| Secondary | Patient-reported Outcomes Scores, Including Euroqol-5D (EQ-5D), Global Rating of Change Scale (GRoC), and Single Alpha Numeric Evaluation (SANE). |
| 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. | Posted | Mean | Standard Deviation | score on a scale | 6 months post-surgery |
|
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | 6 months after surgery |
|
|
|
| 0 |
| 50 |
| 0 |
| 50 |
| 4 |
| 50 |
| EG001 | Saline | Normal saline Normal saline | 0 | 50 | 0 | 50 | 0 | 50 |
| EG002 | Intravenous Tranexamic Acid (TXA) | Intravenous Tranexamic acid (TXA) | 0 | 66 | 0 | 66 | 4 | 66 |
|
| hematoma | Vascular disorders | Non-systematic Assessment |
|
| deep vein thrombosis | Vascular disorders | Non-systematic Assessment |
|
| Aneurysm | Vascular disorders | Non-systematic Assessment |
|
Not provided
Not provided
Not provided
| D000077324 |
| Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| SANE |
|