Tranexamic Acid (TXA) in Hip Arthroscopy

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Hip Pain Chronic; Blood Loss; Hip Injuries; Femoro Acetabular Impingement; Hip Impingement Syndrome
• Intervention / Treatment: Drug: Tranexamic acid; Drug: Placebo

• Study Type: Interventional
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern University Feinberg School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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.	Drug: Tranexamic acid; 1 injection of 15mg/kg of TXA in 100mL of normal saline; Other Names: TXA; Cyklokapron
PLACEBO_COMPARATOR: Placebo; Patients will be injected with 100mL of normal saline via IV access normally established for this procedure.	Drug: Placebo; 1 injection of 100mL of normal saline; Other Names: normal saline

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Northwestern University

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): December 1, 2023
• Primary Completion (ANTICIPATED): March 1, 2024
• Study Completion (ANTICIPATED): September 1, 2024

Study Registration Dates

• First Submitted: August 5, 2022
• First Submitted That Met QC Criteria: January 24, 2023
• First Posted (ACTUAL): February 2, 2023

Study Record Updates

• Last Update Posted (ACTUAL): February 2, 2023
• Last Update Submitted That Met QC Criteria: January 24, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: Hip Arthroscopy; Tranexamic Acid; Intra-operative Blood Loss; Labral Repair of the Hip; Acetabuloplasty
• Additional Relevant MeSH Terms: Pathologic Processes; Wounds and Injuries; Joint Diseases; Musculoskeletal Diseases; Hemorrhage; Hip Injuries; Femoracetabular Impingement; Molecular Mechanisms of Pharmacological Action; Fibrin Modulating Agents; Antifibrinolytic Agents; Hemostatics; Coagulants; Tranexamic Acid
• Other Study ID Numbers: STU#00215778

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes