Tranexamic Acid (TXA) in Hip Arthroscopy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE3

Study Classification

INTERVENTIONAL

Study Start Date

2023-12-31

Study Completion Date

2024-09-30

Brief Summary

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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.

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Detailed Description

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Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Tranexamic acid

Intervention Type DRUG

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

Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

1 injection of 100mL of normal saline

Interventions

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Tranexamic acid

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

Intervention Type DRUG

Placebo

1 injection of 100mL of normal saline

Intervention Type DRUG

Other Intervention Names

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TXA Cyklokapron normal saline

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No