Tranexamic Acid (TXA) in Hip Arthroscopy

NCT05710146 | Withdrawn Phase 3 FDA Drug

• 1 other identifier: STU#00215778
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Intra-operative Visibility Score

  Throughout surgical procedure

• Operative traction time

  Throughout surgical procedure

• Estimated blood loss

  Throughout surgical procedure

• Post-operative dressing changes

  From time of surgery completion through 2 weeks post-op

• Visual Analog Scale (VAS) Pain Score

  Pre-operative baseline up through 24 weeks after surgery

Study Arms (2)

Tranexamic Acid

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

Patients will be injected with 100mL of normal saline via IV access normally established for this procedure.

Drug: Placebo

Interventions

Tranexamic acid DRUG

1 injection of 15mg/kg of TXA in 100mL of normal saline

Also known as: TXA, Cyklokapron

Tranexamic Acid

Placebo DRUG

1 injection of 100mL of normal saline

Also known as: normal saline

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Northwestern University: lead

Study Sites (1)

Northwestern University Feinberg School of Medicine

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Conditions

Hip Injuries; Hemorrhage; Femoracetabular Impingement

Interventions

Tranexamic Acid; Saline Solution

Condition Hierarchy (Ancestors)

Wounds and Injuries; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Joint Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Vehniah K Tjong, MD

  Northwestern Feinberg School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: August 5, 2022
• First Posted: February 2, 2023
• Study Start: December 1, 2023
• Primary Completion: March 1, 2024
• Study Completion: September 1, 2024
• Last Updated: February 2, 2023

Record last verified: 2023-01

Locations

US (1)