Hip Pain ChronicPhase 3NCT05710146
Tranexamic Acid (TXA) in Hip Arthroscopy
A Phase 3 study testing Tranexamic acid in people with Hip Pain Chronic and Hip Impingement Syndrome, run by Northwestern University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hip Pain Chronic, Hip Impingement Syndrome, Hip Injuries
- What is being tested?
- Tranexamic acid
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2023to Sep 2024
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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 locations and contacts
1 site in 1 country.
United States1 site
Northwestern University Feinberg School of Medicine
Chicago, Illinois, 60611
About this study
Official title: Assessing the Efficacy of Tranexamic Acid (TXA) in Hip Arthroscopy: A Randomized, Controlled Trial
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.
- Conditions
- Hip Pain Chronic, Hip Impingement Syndrome, Hip Injuries, Blood Loss, Femoro Acetabular Impingement
- Being tested
- Tranexamic acid, Placebo
- Keywords
- Hip Arthroscopy, Tranexamic Acid, Intra-operative Blood Loss, Labral Repair of the Hip, Acetabuloplasty
- Medical subject headings
- Hip Injuries, Hemorrhage, Femoracetabular Impingement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tranexamic acidDrug
Also called TXA, Cyklokapron
1 injection of 15mg/kg of TXA in 100mL of normal saline
PlaceboDrug
Also called normal saline
1 injection of 100mL of normal saline
| Study group | Role | What they receive |
|---|---|---|
| Tranexamic Acid | Experimental | Patients will be injected with 15 mg/kg of tranexamic acid in 100mL of normal saline via IV access normally established for this procedure. Receives: Drug: Tranexamic acid |
| Placebo | Placebo comparator | Patients will be injected with 100mL of normal saline via IV access normally established for this procedure. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Throughout surgical procedure
Secondary outcomes (9)
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
Measured: Throughout surgical procedure
Operative traction time
Minutes of the procedure in traction
Measured: Throughout surgical procedure
Estimated blood loss
Estimated blood loss during procedure in mL
Measured: Throughout surgical procedure
Post-operative dressing changes
Count number of times post-op dressing was changed
Measured: 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)
Measured: Pre-operative baseline up through 24 weeks after surgery
Complications
Number of complications and type of complication will be recorded
Measured: From surgery start time through first 6 months post-op
Thromboembolic events
Number of thromboembolic events
Measured: From surgery start time through first 6 months post-op
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.
Measured: Pre-operative baseline up through 24 weeks after surgery
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.
Measured: Pre-operative baseline up through 24 weeks after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2023
- Study startDec 2023 (estimated)
- Primary completionMar 2024 (estimated)
- Study completionSep 2024 (estimated)
Why it stopped: Study was never started. Did not receive funding.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip Pain ChronicStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vehniah Tjong, Northwestern University
- Investigators
- Vehniah K Tjong, MD, Principal investigator, Northwestern Feinberg School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05710146
- Sponsor's protocol ID
- STU#00215778
- Status last verified
- Jan 2023
- First submitted
- 5 Aug 2022
- Last updated
- 2 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Efficacy of Tranexamic Acid (TXA) in Hip Arthroscopy: A Randomized, Controlled Trial
- ClinicalTrials.gov ID
- NCT05710146
- Acronym / sponsor ID
- STU#00215778
- Conditions
- 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
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study was never started. Did not receive funding.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Study start
- Dec 2023 (estimated)
- Primary completion
- Mar 2024 (estimated)
- Study completion
- Sep 2024 (estimated)
- First posted
- 2 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tranexamic Acid | Experimental | Drug: Tranexamic acidPatients will be injected with 15 mg/kg of tranexamic acid in 100mL of normal saline via IV access normally established for this procedure. |
| Placebo | Placebo comparator | Drug: PlaceboPatients will be injected with 100mL of normal saline via IV access normally established for this procedure. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tranexamic acidAlso: TXA, Cyklokapron1 injection of 15mg/kg of TXA in 100mL of normal saline | Drug | Tranexamic Acid |
| PlaceboAlso: normal saline1 injection of 100mL of normal saline | Drug | Placebo |
Primary outcome
Visual clarity grade
Time frame: Throughout surgical procedure
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
9 secondary outcomes
Intra-operative Visibility Score
Time frame: Throughout surgical procedure
Operative traction time
Time frame: Throughout surgical procedure
Estimated blood loss
Time frame: Throughout surgical procedure
Post-operative dressing changes
Time frame: From time of surgery completion through 2 weeks post-op
Visual Analog Scale (VAS) Pain Score
Time frame: Pre-operative baseline up through 24 weeks after surgery
Complications
Time frame: From surgery start time through first 6 months post-op
Thromboembolic events
Time frame: From surgery start time through first 6 months post-op
modified Harris Hip Score (mHHS)
Time frame: Pre-operative baseline up through 24 weeks after surgery
International Hip Outcome Tool 12 (iHOT)
Time frame: Pre-operative baseline up through 24 weeks after surgery
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vehniah K Tjong, MD principal investigator
Northwestern Feinberg School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Tranexamic acid in people with Hip Pain Chronic and Hip Impingement Syndrome, run by Northwestern University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 2 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual clarity grade (time frame: Throughout surgical procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2023.