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The primary goal of this study will be to determine if perioperative IV Tranexamic Acid (TXA) administration will reduce intra-operative bleeding and subsequently improve visual clarity during surgery and reduce operative traction time in patients undergoing hip arthroscopy. Additionally, this study aims to determine whether IV TXA injections will reduce post-operative pain and affect hip-specific patient-reported outcomes in patients undergoing hip arthroscopy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tranexamic Acid | Experimental | Patients will be injected with 15 mg/kg of tranexamic acid in 100mL of normal saline via IV access normally established for this procedure. |
|
| Placebo | Placebo Comparator | Patients will be injected with 100mL of normal saline via IV access normally established for this procedure. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tranexamic acid | Drug | 1 injection of 15mg/kg of TXA in 100mL of normal saline |
|
| Measure | Description | Time Frame |
|---|---|---|
| Visual clarity grade | Surgeon-Reported Visual Clarity Grade Grade 1: Active bleeding leading to poor visibility Grade 2: Moderate amount of blood mixed with the irrigation fluid, where the visibility is slightly affected but is acceptable for operating Grade 3: Little or no bleeding; the visibility is excellent to perform the operation | Throughout surgical procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Intra-operative Visibility Score | Number of intra-operative flushes required. Scores as follows:
| Throughout surgical procedure |
| Operative traction time |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Vehniah K Tjong, MD | Northwestern Feinberg School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northwestern University Feinberg School of Medicine | Chicago | Illinois | 60611 | United States |
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| ID | Term |
|---|---|
| D025981 | Hip Injuries |
| D006470 | Hemorrhage |
| D057925 | Femoracetabular Impingement |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007592 | Joint Diseases |
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| ID | Term |
|---|---|
| D014148 | Tranexamic Acid |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D003509 | Cyclohexanecarboxylic Acids |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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| Placebo | Drug | 1 injection of 100mL of normal saline |
|
|
Minutes of the procedure in traction |
| Throughout surgical procedure |
| Estimated blood loss | Estimated blood loss during procedure in mL | Throughout surgical procedure |
| Post-operative dressing changes | Count number of times post-op dressing was changed | From time of surgery completion through 2 weeks post-op |
| Visual Analog Scale (VAS) Pain Score | Scored from 0 (no pain) to 10 (worst possible pain) | Pre-operative baseline up through 24 weeks after surgery |
| Complications | Number of complications and type of complication will be recorded | From surgery start time through first 6 months post-op |
| Thromboembolic events | Number of thromboembolic events | From surgery start time through first 6 months post-op |
| modified Harris Hip Score (mHHS) | Subscales regarding pain severity (1 item, 0-44 points), and function (7 items, 0-47 points). Higher overall score corresponds to less disability. | Pre-operative baseline up through 24 weeks after surgery |
| International Hip Outcome Tool 12 (iHOT) | 12 questions scored from 0 to 100, with 100 being the best function and least amount of symptoms. The final iHOT score equates to the mean of the 12 scores. | Pre-operative baseline up through 24 weeks after surgery |
| D009140 | Musculoskeletal Diseases |
| D000077324 |
| Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |