Tranexamic Acid (TXA) in Hip Arthroscopy

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Primary Purpose

Status

Withdrawn

Phase

Phase 3

Locations

United States

Study Type

Interventional

Intervention

Tranexamic acid

Placebo

About this trial

This is an interventional treatment trial for Hip Pain Chronic focused on measuring Hip Arthroscopy, Tranexamic Acid, Intra-operative Blood Loss, Labral Repair of the Hip, Acetabuloplasty

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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)

Sites / Locations

Northwestern University Feinberg School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Tranexamic Acid

Placebo

Arm 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.

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Operative traction time

Minutes of the procedure in traction

Estimated blood loss

Estimated blood loss during procedure in mL

Post-operative dressing changes

Count number of times post-op dressing was changed

Visual Analog Scale (VAS) Pain Score

Scored from 0 (no pain) to 10 (worst possible pain)

Complications

Number of complications and type of complication will be recorded

Thromboembolic events

Number of thromboembolic events

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.

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.

Full Information

NCT ID

NCT05710146

First Posted

August 5, 2022

Last Updated

January 24, 2023

Sponsor

Northwestern University

1. Study Identification

Unique Protocol Identification Number

NCT05710146

Brief Title

Tranexamic Acid (TXA) in Hip Arthroscopy

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2023

Overall Recruitment Status

Withdrawn

Why Stopped

Study was never started. Did not receive funding.

Study Start Date

December 2023 (Anticipated)

Primary Completion Date

March 2024 (Anticipated)

Study Completion Date

September 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Northwestern University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

No

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Tranexamic Acid

Arm Type

Experimental

Arm 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.

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Tranexamic acid

Other Intervention Name(s)

TXA, Cyklokapron

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Placebo

Other Intervention Name(s)

normal saline

Intervention Description

1 injection of 100mL of normal saline

Primary Outcome Measure Information:

Title

Visual clarity grade

Description

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 Outcome Measure Information:

Title

Intra-operative Visibility Score

Description

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

Time Frame

Throughout surgical procedure

Title

Operative traction time

Description

Minutes of the procedure in traction

Time Frame

Throughout surgical procedure

Title

Estimated blood loss

Description

Estimated blood loss during procedure in mL

Time Frame

Throughout surgical procedure

Title

Post-operative dressing changes

Description

Count number of times post-op dressing was changed

Time Frame

From time of surgery completion through 2 weeks post-op

Title

Visual Analog Scale (VAS) Pain Score

Description

Scored from 0 (no pain) to 10 (worst possible pain)

Time Frame

Pre-operative baseline up through 24 weeks after surgery

Title

Complications

Description

Number of complications and type of complication will be recorded

Time Frame

From surgery start time through first 6 months post-op

Title

Thromboembolic events

Description

Number of thromboembolic events

Time Frame

From surgery start time through first 6 months post-op

Title

modified Harris Hip Score (mHHS)

Description

Subscales regarding pain severity (1 item, 0-44 points), and function (7 items, 0-47 points). Higher overall score corresponds to less disability.

Time Frame

Pre-operative baseline up through 24 weeks after surgery

Title

International Hip Outcome Tool 12 (iHOT)

Description

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.

Time Frame

Pre-operative baseline up through 24 weeks after surgery

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

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)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Vehniah K Tjong, MD

Organizational Affiliation

Northwestern Feinberg School of Medicine

Official's Role

Principal Investigator

Facility Information:

Facility Name

Northwestern University Feinberg School of Medicine

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60611

Country

United States

Hip Pain Chronic, Hip Impingement Syndrome, Hip Injuries

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial