Tranexamic Acid (TXA) in Hip Arthroscopy

Study Overview
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Brief Summary
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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.

Official Title
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Assessing the Efficacy of Tranexamic Acid (TXA) in Hip Arthroscopy: A Randomized, Controlled Trial

Conditions
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Hip Pain Chronic, Hip Impingement Syndrome, Hip Injuries, Blood Loss, Femoro Acetabular Impingement

Intervention / Treatment
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* Drug: Tranexamic acid
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18 years or older Scheduled to undergo primary hip arthroscopy for any intra-articular procedure Able to complete and understand study materials in English Exclusion Criteria: Age under 18 years Cannot complete and understand study materials in English Patients undergoing revision surgery Patients who have had previous surgery to the study joint Patients on drugs that interfere with coagulation or TXA clearance Patients with a known allergy to TXA Patients with any of the following comorbidities Bleeding and/or coagulative disorders Renal impairment Sickle cell disease Thrombotic diseases Comorbidities preventing surgery (including pregnancy)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tranexamic Acid<br>Patients will be injected with 15 mg/kg of tranexamic acid in 100mL of normal saline via IV access normally established for this procedure. | Drug: Tranexamic acid<br>* 1 injection of 15mg/kg of TXA in 100mL of normal saline<br>* Other names: Cyklokapron;|
| Placebo Comparator: Placebo<br>Patients will be injected with 100mL of normal saline via IV access normally established for this procedure. | Drug: Placebo<br>* 1 injection of 100mL of normal saline<br>* Other names: normal saline;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intra-operative Visibility Score | Number of intra-operative flushes required. Scores as follows: Greater than 13 saline flushes 8-12 saline flushes 4-7 saline flushes 1-3 saline flushes 5 = Zero saline flushes | Throughout surgical procedure | 
| Operative traction time | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hip Arthroscopy, Tranexamic Acid, Intra-operative Blood Loss, Labral Repair of the Hip, Acetabuloplasty