Tranexamic Acid (TXA) in Hip Arthroscopy
- Conditions
- Hip Pain ChronicFemoro Acetabular ImpingementHip InjuriesBlood LossHip Impingement Syndrome
- Interventions
- Drug: PlaceboDrug: Tranexamic acid
- Registration Number
- NCT05710146
- Lead Sponsor
- Northwestern University
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
- 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
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Patients will be injected with 100mL of normal saline via IV access normally established for this procedure. Tranexamic Acid Tranexamic acid Patients will be injected with 15 mg/kg of tranexamic acid in 100mL of normal saline via IV access normally established for this procedure.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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 flushesVisual Analog Scale (VAS) Pain Score Pre-operative baseline up through 24 weeks after surgery Scored from 0 (no pain) to 10 (worst possible pain)
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.
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
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.
Operative traction time Throughout surgical procedure Minutes of the procedure in traction
Complications From surgery start time through first 6 months post-op Number of complications and type of complication will be recorded
Trial Locations
- Locations (1)
Northwestern University Feinberg School of Medicine
🇺🇸Chicago, Illinois, United States