Clinical trial NCT05710146: Tranexamic Acid (TXA) in Hip Arthroscopy
Official title: Assessing the Efficacy of Tranexamic Acid (TXA) in Hip Arthroscopy: A Randomized, Controlled Trial
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Hip Pain Chronic
Hip Impingement Syndrome
Hip Injuries
Blood Loss
Femoro Acetabular Impingement
Keywords: Hip Arthroscopy
Tranexamic Acid
Intra-operative Blood Loss
Labral Repair of the Hip
Acetabuloplasty
Lead sponsor: Northwestern University
Sponsor class: OTHER
First posted: 2023-02-02
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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)

Primary outcomes:
measure: Visual clarity grade
timeFrame: Throughout surgical procedure
Secondary outcomes:
measure: Intra-operative Visibility Score
timeFrame: Throughout surgical procedure
measure: Operative traction time
timeFrame: Throughout surgical procedure
measure: Estimated blood loss
timeFrame: Throughout surgical procedure
measure: Post-operative dressing changes
timeFrame: From time of surgery completion through 2 weeks post-op
measure: Visual Analog Scale (VAS) Pain Score
timeFrame: Pre-operative baseline up through 24 weeks after surgery
measure: Complications
timeFrame: From surgery start time through first 6 months post-op
measure: Thromboembolic events
timeFrame: From surgery start time through first 6 months post-op
measure: modified Harris Hip Score (mHHS)
timeFrame: Pre-operative baseline up through 24 weeks after surgery
measure: International Hip Outcome Tool 12 (iHOT)
timeFrame: Pre-operative baseline up through 24 weeks after surgery
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern University Feinberg School of Medicine
state: Illinois
Study officials:
affiliation: Northwestern Feinberg School of Medicine
name: Vehniah K Tjong, MD
role: PRINCIPAL_INVESTIGATOR
References: