Tranexamic Acid for ACL Surgery

Not yet recruiting at 5 trial locations

Overseen By Emily Holmquist, MBA

Age: < 65

Sex: Any

Trial Phase: Phase 4

Sponsor: Campbell Clinic

Must not be taking: Hormonal contraception

Disqualifiers: Revision ACLR, DVT history, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 4

Duration: 10 days

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether oral tranexamic acid (TXA) after ACL surgery can reduce pain and improve recovery. It focuses on young people who have had their ACL reconstructed using a piece of their patellar tendon. Participants will receive either TXA or a placebo (a pill with no active drug) for 10 days post-surgery. Ideal candidates are aged 14 to 22, undergoing ACL surgery with a patellar tendon graft, and fluent in English. The trial aims to determine if TXA can ease pain and help patients quickly regain knee strength and return to sports. As a Phase 4 trial, this research involves an FDA-approved treatment and seeks to understand how TXA benefits more patients.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, if you are using combination hormonal contraception, you cannot participate in the trial.

What is the safety track record for tranexamic acid?

Research has shown that tranexamic acid (TXA) is generally safe for surgeries like ACL reconstruction. In past studies, patients who used TXA experienced fewer bleeding problems, as it helps reduce blood loss during and after surgery.

Reports indicate that TXA use in ACL surgeries can decrease the amount of blood that gathers in the knee joint post-operation, leading to better short-term recovery. Studies have also found no major safety issues with TXA, and most people tolerated it well without serious side effects.

TXA is already used in other surgeries, suggesting it is safe when used properly. Prospective trial participants should discuss any concerns with their doctor. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Tranexamic Acid (TXA) is unique because it is being studied for its potential to reduce bleeding during ACL surgery, which isn't the typical focus of current treatment options like pain management and physical therapy. Unlike these standard care methods that primarily address recovery and pain relief, TXA specifically works to minimize blood loss during and after surgery, potentially leading to quicker recovery times and fewer transfusions. Researchers are excited about TXA because it is administered both intravenously and orally, offering a comprehensive approach to manage bleeding, which could enhance surgical outcomes and patient recovery.

What evidence suggests that tranexamic acid might be an effective treatment for improving postoperative outcomes in ACL surgery?

Research has shown that tranexamic acid (TXA), which participants in this trial may receive, can reduce pain and swelling after anterior cruciate ligament repair (ACLR) surgery. Studies indicate that TXA lowers the need for additional procedures, such as draining fluid from the knee. Evidence also suggests that TXA reduces bleeding and inflammation, aiding recovery. Specifically, TXA decreases bleeding in the joint and improves pain control. These benefits can enhance knee function and strength after surgery. ^{1 2 6 7 8}

Are You a Good Fit for This Trial?

This trial is for young individuals aged 14 to 22 who are undergoing anterior cruciate ligament reconstruction with a patellar tendon autograft. Participants must be suitable for the surgery and willing to take oral medication or placebo post-surgery.

Inclusion Criteria

Fluent in English

I am between 14 and 22 years old and need ACL surgery using a piece of my patellar tendon.

I am willing to participate in the clinical trial.

Exclusion Criteria

I am having or have had a complex knee surgery including ACL repair and additional ligament work.

I have had a blood clot in my veins or a thromboembolic event before.

Known allergy or hypersensitivity to TXA

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants receive oral TXA or placebo from postoperative day 1 to 10, in addition to standard intraoperative care

10 days

Daily administration

Follow-up

Participants are monitored for safety and effectiveness after treatment, with routine postoperative visits

1 year

Routine visits at 2 weeks, 6 weeks, 12 weeks, 6 months, and 1 year

Long-term Follow-up

Participants receive a phone call for patient-reported outcomes at 2 years

2 years

1 phone call

What Are the Treatments Tested in This Trial?

Interventions

• Tranexamic Acid

Trial Overview The study tests if taking oral Tranexamic Acid (TXA) after ACL surgery can improve recovery compared to a placebo. Patients will either get TXA or a fake pill daily for ten days, in addition to standard care including IV TXA during surgery.

How Is the Trial Designed?

Group I: Oral TXA Experimental Treatment 1 Intervention

Participants in this arm will receive oral tranexamic acid (TXA), 1.95 g daily (three 650 mg capsules) from POD 1 to POD 10, for a total of 10 doses (30 capsules). All participants will also receive 1 g IV TXA before incision and 1 g IV TXA at surgical closure as part of standard care.

Group II: Placebo Placebo Group 1 Intervention

Participants in this arm will receive oral placebo capsules (microcrystalline cellulose), 3 capsules daily from postoperative day (POD) 1 to POD 10, for a total of 10 doses (30 capsules). All participants will also receive 1 g IV TXA before incision and 1 g IV TXA at surgical closure as part of standard care.

Who Is Running the Clinical Trial?

Campbell Clinic

Lead Sponsor

Trials

15

Recruited

2,100+

University of Pittsburgh

Collaborator

Trials

1,820

Recruited

16,360,000+

Endeavor Health

Collaborator

Trials

135

Recruited

742,000+

Washington University School of Medicine

Collaborator

Trials

2,027

Recruited

2,353,000+

Duke University

Collaborator

Trials

2,495

Recruited

5,912,000+

University of Cincinnati

Collaborator

Trials

442

Recruited

639,000+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/34358640/

Tranexamic Acid Use in Anterior Cruciate Ligament ... Pooled data suggest that the use of TXA in ACLR reduces the need for aspiration, hemarthrosis, drain output, and knee swelling in the postoperative period.

2. arthroscopyjournal.org arthroscopyjournal.org/article/S0749-8063(21)00725-8/fulltext

Tranexamic Acid Use in Anterior Cruciate Ligament ... Pooled data suggest that the use of TXA in ACLR reduces the need for aspiration, hemarthrosis, drain output, and knee swelling in the ...

3. oarsijournal.com oarsijournal.com/article/S1063-4584(24)00859-8/fulltext

801 - association of tranexamic acid during anterior ... There is growing evidence of its effectiveness after anterior cruciate ligament reconstruction (ACLR) to reduce post-operative hemarthrosis and pain.

4. clinicaltrials.gov clinicaltrials.gov/study/NCT07115056?aggFilters=status%3Anot

Extended Oral Tranexamic Acid After Anterior Cruciate ... This trial aims to clarify the role of extended postoperative oral TXA in reducing inflammation, pain, and bleeding in young ACLR patients, potentially offering ...

5. journals.lww.com journals.lww.com/md-journal/fulltext/2020/08210/the_efficacy_and_safety_of_intravenous_tranexamic.52.aspx

The efficacy and safety of intravenous tranexamic acid in... In addition, some studies have shown that TXA can not only reduce blood loss, but also play a significant role in inflammatory response. The ...

6. sciencedirect.com sciencedirect.com/science/article/pii/S0972978X24004331

Intraoperative tranexamic acid reduces postoperative ... Conclusion. The use of TXA during double-bundle ACLR may reduce postoperative joint haemarthrosis and enhance short-term functional outcomes.

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/32846798/

The efficacy and safety of intravenous tranexamic acid in ... The efficacy and safety of intravenous tranexamic acid in anterior cruciate ligament reconstruction: A randomized controlled trial protocol.

8. bmcmusculoskeletdisord.biomedcentral.com bmcmusculoskeletdisord.biomedcentral.com/articles/10.1186/s12891-021-03990-7

The comparative efficacies of intravenous administration and ... Tranexamic acid during anterior cruciate ligament reconstruction reduced drained blood volume on day 1 and hemarthrosis up to day 15 but did ...