Tranexamic Acid (TXA) in Hip Arthroscopy

Northwestern University

Status and phase: Withdrawn; Phase 3

Conditions: Hip Injuries; Femoro Acetabular Impingement; Hip Impingement Syndrome; Hip Pain Chronic; Blood Loss

Treatments: Drug: Tranexamic acid; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT05710146

STU#00215778

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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0 participants in 2 patient groups, including a placebo group

Tranexamic Acid

Experimental group

Description:

Patients will be injected with 15 mg/kg of tranexamic acid in 100mL of normal saline via IV access normally established for this procedure.

Treatment:

Drug: Tranexamic acid

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo