Tranexamic Acid (TXA) in Hip Arthroscopy

Blood Loss Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05710146
• Other study ID #: STU#00215778
• Status: Withdrawn
• Phase: Phase 3
• Start date: December 2023
• Est. completion date: September 2024

Study information

• Verified date: January 2023
• Source: Northwestern University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 2024
• Est. primary completion date: March 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Blood Loss
• Femoracetabular Impingement
• Femoro Acetabular Impingement
• Hemorrhage
• Hip Impingement Syndrome
• Hip Injuries
• Hip Pain Chronic

Intervention

Drug:
• Tranexamic acid
1 injection of 15mg/kg of TXA in 100mL of normal saline
• Placebo
1 injection of 100mL of normal saline

Locations

Country	Name	City	State
United States	Northwestern University Feinberg School of Medicine	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Northwestern University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Operative traction time	Minutes of the procedure in traction	Throughout surgical procedure
Secondary	Estimated blood loss	Estimated blood loss during procedure in mL	Throughout surgical procedure
Secondary	Post-operative dressing changes	Count number of times post-op dressing was changed	From time of surgery completion through 2 weeks post-op
Secondary	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
Secondary	Complications	Number of complications and type of complication will be recorded	From surgery start time through first 6 months post-op
Secondary	Thromboembolic events	Number of thromboembolic events	From surgery start time through first 6 months post-op
Secondary	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
Secondary	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