Tranexamic Acid (TXA) in Hip Arthroscopy

Northwestern University

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Conditions

Hip Pain Chronic Hip Impingement Syndrome Hip Injuries Blood Loss Femoro Acetabular Impingement

Interventions

Tranexamic acidDRUG

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

PlaceboDRUG

1 injection of 100mL of normal saline

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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)

Locations (1)

Northwestern University Feinberg School of Medicine

Chicago, Illinois, United States

Outcomes

Primary Outcomes

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

Time frame: Throughout surgical procedure

Secondary Outcomes

Intra-operative Visibility Score

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

Time frame: Throughout surgical procedure

Operative traction time

Minutes of the procedure in traction

Time frame: Throughout surgical procedure

Estimated blood loss

Estimated blood loss during procedure in mL

Time frame: Throughout surgical procedure

Post-operative dressing changes

Count number of times post-op dressing was changed

Time frame: 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)

Time frame: Pre-operative baseline up through 24 weeks after surgery

Complications

Number of complications and type of complication will be recorded

Time frame: From surgery start time through first 6 months post-op

Data from ClinicalTrials.gov

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