MedPath

Tranexamic Acid (TXA) in Hip Arthroscopy

Phase 3
Withdrawn
Conditions
Hip Pain Chronic
Femoro Acetabular Impingement
Hip Injuries
Blood Loss
Hip Impingement Syndrome
Interventions
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WITHDRAWN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
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
Read More
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)
Read More

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
PlaceboPlaceboPatients will be injected with 100mL of normal saline via IV access normally established for this procedure.
Tranexamic AcidTranexamic acidPatients 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
NameTimeMethod
Visual clarity gradeThroughout 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
NameTimeMethod
Intra-operative Visibility ScoreThroughout 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

Visual Analog Scale (VAS) Pain ScorePre-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 lossThroughout surgical procedure

Estimated blood loss during procedure in mL

Post-operative dressing changesFrom time of surgery completion through 2 weeks post-op

Count number of times post-op dressing was changed

Thromboembolic eventsFrom 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 timeThroughout surgical procedure

Minutes of the procedure in traction

ComplicationsFrom 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

© Copyright 2025. All Rights Reserved by MedPath