Anterior Cruciate Ligament ReconstructionPhase 4NCT03631355

Reducing Hemarthrosis in ACL Reconstruction With BTB Autograft by the Administration of Intravenous TXA

A Phase 4 study testing Tranexamic Acid in people with Anterior Cruciate Ligament Reconstruction, run by NYU Langone Health at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 60 years
Conditions the study is for: Anterior Cruciate Ligament Reconstruction
What is being tested?: Tranexamic Acid
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 110 participants
Where: 1 siteUnited States
Study dates: 6 Jun 2018to 1 Mar 2020
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 to 60 years
All sexes
No healthy volunteers
Adult

Who may be able to join

-PATIENTS UNDERGOING AN ACL RECONSTRUCTION WITH BTB AUTOGRAFT

Who cannot join

Legally incompetent or mentally impaired (e.g., minors, Alzheimer's subjects, dementia, etc.)
Younger than 18 years of age
Any patient considered a vulnerable subject
Have bleeding or clotting disorder
Preoperative anticoagulation therapy
Abnormal coagulation profile
Renal disorder or insufficiency
Sickle cell disease

Trial locations and contacts

1 site in 1 country.

United States1 site

New York University School of Medicine
New York, New York, 10016

Other trials in United States

About this study

Official title: Reducing Hemarthrosis in Anterior Cruciate Ligament Reconstruction With BTB Autograft by the Administration of Intravenous Tranexamic Acid: A Double-Blind Randomized Control Study

Read the detailed description

The purpose of the proposed study is to evaluate the effects of administering intravenous tranexamic acid (TXA) to patients undergoing anterior cruciate ligament (ACL) reconstruction with bone-patellar tendon-bone autograft to minimize hemarthrosis within the knee joint and post operative pain. Patients received the standard arthroscopic ACL reconstruction with a BTB autograft and were randomized to either receiving or not receiving two individual doses of TXA intra-operatively or receive. The goal of the study is to determine and evaluate the effect of intra-operative TXA on post-operative hemarthrosis, pain reduction, and opioid consumption.

Conditions: Anterior Cruciate Ligament Reconstruction
Being tested: Tranexamic Acid

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Tranexamic AcidDrug
One gram of intravenous tranexamic acid will be administered before tourniquet inflation and 1 gram of IV TXA before closure of the incision.

Study groups in NCT03631355
Study group	Role	What they receive
ACL Reconstruction w/ BTB Autograft + IV TXA	Active comparator	Patients receive a standard arthroscopic ACL reconstruction with a BTB autograft. In addition, these selected patients received two individual doses of intravenous TXA intra-operatively. Receives: Drug: Tranexamic Acid
ACL Reconstruction w/ BTB Autograft, no IV TXA	No intervention	Patients receive a standard arthroscopic ACL reconstruction with a BTB autograft. In addition, these selected patients did not receive two individual doses of intravenous TXA intra-operatively. Only the consented surgery was performed.

What is being measured

The primary outcome is the main question the study is designed to answer.

POST-OPERATIVE HEMARTHROSIS
Measured by assessing the operative knee at the first post-operative visit for the need of joint aspiration.
Measured: Post-operative week 1
POST-OPERATIVE Opioid Consumption
Each patient's opioid consumption was measured by morphine milligram equivalents (MME).
Measured: Days 1-7
POST-OPERATIVE Patient Reported Pain Score on the Visual Analog Scale (VAS)
Pain severity, measured by the Visual Analog Scale (VAS): a scale of 1-10, with 1 being the least amount of pain and 10 being the most amount of pain.
Measured: Post-operative day 7

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

6 Jun 20181 Mar 2020

First posted15 Aug 2018
Study start6 Jun 2018
Primary completion1 Mar 2020
Study completion1 Mar 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Anterior Cruciate Ligament ReconstructionStudies of the same condition, open and under way.
More trials run by NYU Langone HealthThe 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 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 110 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03631355
Sponsor's protocol ID: 18-00538
Status last verified: Feb 2021
First submitted: 10 Aug 2018
Last updated: 24 Feb 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Stair Biomechanics and Vibration Study After ACLR
Anterior Cruciate Ligament Reconstruction (ACLR), Anterior Cruciate Ligament Injury
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Nerve Block of the Vastus Medialis and Anterior Obturator Branch in Anterior Cruciate Ligament Reconstruction With DIDT Graft
Anterior Cruciate Ligament (ACL) Reconstruction Surgery
Not yet recruiting
Supporting Athletes' Return to Sports After ACL Reconstruction: A Study of a Psychological Readiness Program
Anterior Cruciate Ligament Reconstruction, Anterior Cruciate Ligament Injuries
Recruiting
Interventions to Enhance Quadriceps Output After ACLR
ACL
Recruiting
Graded Exposure and Mindfulness Meditation for Patients Post-ACL Reconstruction
Anterior Cruciate Ligament Injuries

All Anterior Cruciate Ligament Reconstruction trials

Study at a glance

From the registry record, last updated by the sponsor on 24 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Reducing Hemarthrosis in Anterior Cruciate Ligament Reconstruction With BTB Autograft by the Administration of Intravenous Tranexamic Acid: A Double-Blind Randomized Control Study
ClinicalTrials.gov ID: NCT03631355
Acronym / sponsor ID: 18-00538
Conditions: Anterior Cruciate Ligament Reconstruction
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 110 participants (actual)
Lead sponsor: NYU Langone HealthUniversity, hospital or other
Study start: 6 Jun 2018 (actual)
Primary completion: 1 Mar 2020 (actual)
Study completion: 1 Mar 2020 (actual)
First posted: 15 Aug 2018 (actual)
Results: Posted 24 Feb 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
ACL Reconstruction w/ BTB Autograft + IV TXA	Active comparator	Drug: Tranexamic AcidPatients receive a standard arthroscopic ACL reconstruction with a BTB autograft. In addition, these selected patients received two individual doses of intravenous TXA intra-operatively.
ACL Reconstruction w/ BTB Autograft, no IV TXA	No intervention	–Patients receive a standard arthroscopic ACL reconstruction with a BTB autograft. In addition, these selected patients did not receive two individual doses of intravenous TXA intra-operatively. Only the consented surgery was performed.

Who may qualify

Ages: 18 to 60 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (1 listed)

-PATIENTS UNDERGOING AN ACL RECONSTRUCTION WITH BTB AUTOGRAFT

Key exclusion criteria (8 listed)

Legally incompetent or mentally impaired (e.g., minors, Alzheimer's subjects, dementia, etc.)
Younger than 18 years of age
Any patient considered a vulnerable subject
Have bleeding or clotting disorder
Preoperative anticoagulation therapy

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 AcidOne gram of intravenous tranexamic acid will be administered before tourniquet inflation and 1 gram of IV TXA before closure of the incision.	Drug	ACL Reconstruction w/ BTB Autograft + IV TXA

Primary outcome

POST-OPERATIVE HEMARTHROSIS
Time frame: Post-operative week 1
Measured by assessing the operative knee at the first post-operative visit for the need of joint aspiration.
POST-OPERATIVE Opioid Consumption
Time frame: Days 1-7
Each patient's opioid consumption was measured by morphine milligram equivalents (MME).
POST-OPERATIVE Patient Reported Pain Score on the Visual Analog Scale (VAS)
Time frame: Post-operative day 7
Pain severity, measured by the Visual Analog Scale (VAS): a scale of 1-10, with 1 being the least amount of pain and 10 being the most amount of pain.

Results and safety

Results posted to the registry on 24 Feb 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
ACL Reconstruction w/ BTB Autograft + IV TXA	55	54
ACL Reconstruction w/ BTB Autograft, no IV TXA	55	53

Primary outcome: POST-OPERATIVE HEMARTHROSIS

Time frame: Post-operative week 1. Mean (Standard Deviation). Unit: ml

Measure	ACL Reconstruction w/ BTB Autograft + IV TXA n = 23	ACL Reconstruction w/ BTB Autograft, no IV TXA n = 26
Value	26.7 (23.1)	37.3 (23.2)

Population analysed: The patients in each respective arm were evaluated for knee joint hemarthrosis and prompted joint aspiration because of pain or significant swelling.

Primary outcome: POST-OPERATIVE Opioid Consumption

Time frame: Days 1-7. Mean (Standard Deviation). Unit: MME

Measure	ACL Reconstruction w/ BTB Autograft + IV TXA n = 54	ACL Reconstruction w/ BTB Autograft, no IV TXA n = 53
Value	130.9 (90.9)	113.9 (85.0)

Primary outcome: POST-OPERATIVE Patient Reported Pain Score on the Visual Analog Scale (VAS)

Time frame: Post-operative day 7. Mean (Standard Deviation). Unit: score on a scale

Measure	ACL Reconstruction w/ BTB Autograft + IV TXA n = 54	ACL Reconstruction w/ BTB Autograft, no IV TXA n = 53
Value	2.7 (1.9)	3.2 (1.8)

Adverse events

Time frame: 3 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
ACL Reconstruction w/ BTB Autograft + IV TXA	0 of 55 (0%)	0 of 55 (0%)	0 of 55
ACL Reconstruction w/ BTB Autograft, no IV TXA	0 of 55 (0%)	0 of 55 (0%)	0 of 55

Limitations and caveats (from the sponsor): Possibility of observer bias is present as we did not perform in-office aspirations in patients in whom we thought the hemarthroses were not clinically significant, as these procedures can be painful and confer some risk of infection. Despite the decision to aspirate being made clinically, post-study analysis revealed no difference in the rate each surgeon performed an aspiration.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Anterior Cruciate Ligament Reconstruction

Not yet recruiting
Stair Biomechanics and Vibration Study After ACLR
Anterior Cruciate Ligament Reconstruction (ACLR), Anterior Cruciate Ligament Injury
Not yet recruiting
Nerve Block of the Vastus Medialis and Anterior Obturator Branch in Anterior Cruciate Ligament Reconstruction With DIDT Graft
Anterior Cruciate Ligament (ACL) Reconstruction Surgery
Not yet recruiting
Supporting Athletes' Return to Sports After ACL Reconstruction: A Study of a Psychological Readiness Program
Anterior Cruciate Ligament Reconstruction, Anterior Cruciate Ligament Injuries
Recruiting
Interventions to Enhance Quadriceps Output After ACLR
ACL
Recruiting
Graded Exposure and Mindfulness Meditation for Patients Post-ACL Reconstruction
Anterior Cruciate Ligament Injuries

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.

Michael Alaia, MD principal investigator

NYU Langone Health

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Tranexamic Acid in people with Anterior Cruciate Ligament Reconstruction, run by NYU Langone Health 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 1 inclusion and 8 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: finished, as of the sponsor's last update on 24 Feb 2021. 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 24 Feb 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

POST-OPERATIVE HEMARTHROSIS (time frame: Post-operative week 1). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03631355.

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 24 Feb 2021.