Blood Loss, Femoro Acetabular Impingement, Hip Impingement Syndrome, Hip Injuries, Hip Pain Chronic
Conditions
Keywords
Hip Arthroscopy, Tranexamic Acid, Intra-operative Blood Loss, Labral Repair of the Hip, Acetabuloplasty
Brief summary
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.
Interventions
DRUGTranexamic acid
1 injection of 15mg/kg of TXA in 100mL of normal saline
DRUGPlacebo
1 injection of 100mL of normal saline
Sponsors
Northwestern University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual clarity grade | Throughout surgical procedure | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Operative traction time | Throughout surgical procedure | Minutes of the procedure in traction |
| Estimated blood loss | Throughout surgical procedure | Estimated blood loss during procedure in mL |
| Post-operative dressing changes | From time of surgery completion through 2 weeks post-op | Count number of times post-op dressing was changed |
| Visual Analog Scale (VAS) Pain Score | Pre-operative baseline up through 24 weeks after surgery | Scored from 0 (no pain) to 10 (worst possible pain) |
| Intra-operative Visibility Score | Throughout surgical procedure | Number of intra-operative flushes required. Scores as follows: 1. Greater than 13 saline flushes 2. 8-12 saline flushes 3. 4-7 saline flushes 4. 1-3 saline flushes 5 = Zero saline flushes |
| Thromboembolic events | From surgery start time through first 6 months post-op | Number of thromboembolic events |
| modified Harris Hip Score (mHHS) | Pre-operative baseline up through 24 weeks after surgery | Subscales regarding pain severity (1 item, 0-44 points), and function (7 items, 0-47 points). Higher overall score corresponds to less disability. |
| International Hip Outcome Tool 12 (iHOT) | Pre-operative baseline up through 24 weeks after surgery | 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. |
| Complications | From surgery start time through first 6 months post-op | Number of complications and type of complication will be recorded |
Countries
United States
Outcome results
None listed