Tranexamic Acid for Post-ACL Injury Arthritis

Overseen By Christine L Hoang, BS

Age: 18 - 65

Sex: Any

Trial Phase: Phase 2

Sponsor: Stanford University

Must not be taking: Hormonal contraception, NSAIDs

Disqualifiers: Inflammatory arthritis, Osteoarthritis, Gout, others

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

Approved in 5 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 5 days

50 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines whether Tranexamic Acid, a medicine that reduces bleeding, can help prevent arthritis in individuals with a torn ACL (a key ligament in the knee). The researchers aim to determine if taking this medicine immediately after an ACL injury and surgery can reduce inflammation and protect the knee joint from arthritis, which often develops later. Participants may qualify if they are 18-30 years old and have experienced an ACL injury within the past four days, accompanied by knee swelling. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, allowing participants to contribute to important findings.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it excludes people with certain conditions or those using specific medications like chronic NSAIDs or combination hormonal contraception.

Is there any evidence suggesting that Tranexamic Acid is likely to be safe for humans?

Research has shown that Tranexamic Acid (TXA) is generally safe for people. The FDA has approved it to help reduce bleeding in various situations, including surgeries. One study found that using TXA during ACL (anterior cruciate ligament) surgery reduced bleeding without major safety concerns. Another study demonstrated that injecting TXA into the joint during ACL surgery reduced pain and bleeding.

These results suggest that TXA is well-tolerated when used around the time of ACL surgery. Notably, these studies have not reported significant serious side effects, indicating good safety. Always consult healthcare professionals to determine if joining a trial is appropriate. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Tranexamic acid is unique because it could potentially prevent post-ACL injury arthritis by reducing inflammation and tissue breakdown. Unlike standard treatments that primarily focus on symptom relief, tranexamic acid works by stabilizing blood clots and minimizing bleeding during surgery, which might lead to less joint damage in the long run. Researchers are excited about this approach as it targets the root cause of arthritis development rather than just managing its symptoms.

What evidence suggests that Tranexamic Acid might be an effective treatment for post-ACL injury arthritis?

Research has shown that Tranexamic Acid (TXA), which participants in this trial may receive, reduces bleeding during joint surgeries, lowering the risk of complications like swelling and pain. Studies indicate that TXA decreases bleeding into the joint, swelling, and pain after surgery, leading to better joint function. Specifically, patients who received TXA after ACL injuries experienced improved knee function and less inflammation. By reducing bleeding and inflammation, TXA may help protect joint health and delay the onset of arthritis that can occur after injuries. These findings suggest that TXA could effectively prevent or delay arthritis following ACL injuries. ^{1 3 6 7 8}

Who Is on the Research Team?

Constance Chu, MD

Principal Investigator

Stanford University

Are You a Good Fit for This Trial?

This trial is for young adults aged 18-30 who have recently (within 4 days) injured their ACL and have joint swelling. It's not for those with a history of knee issues, arthritis, gout, recent cortisone injections to the knee, or thromboembolic disease. People using certain contraceptives or chronic NSAIDs are also excluded.

Inclusion Criteria

You have experienced an injury to your knee's anterior cruciate ligament (ACL) within the past four days.

You injured your ACL (a ligament in your knee) on one side within the past 4 days.

Presence of effusion/hemarthrosis

Exclusion Criteria

You have received a cortisone injection in either knee within the last 3 months.

Radiographic osteoarthritis (K-L Grade 2 or higher)

Gout/pseudogout

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Tranexamic Acid or placebo during ACL reconstruction surgery and for 5 days post-surgery

5 days

1 visit (in-person for surgery)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments at 6 months and 2 years post-ACLR

2 years

Multiple visits (in-person for assessments)

What Are the Treatments Tested in This Trial?

Interventions

• Tranexamic Acid

Trial Overview The study tests if Tranexamic Acid (TXA), which reduces bleeding after an ACL injury and surgery, can lessen inflammation and improve joint health to prevent or delay arthritis onset compared to a placebo.

How Is the Trial Designed?

Group I: Tranexamic Acid Experimental Treatment 1 Intervention

5-day course of standard adult oral tranexamic acid dosage of 1300 mg taken 3 times a day (3900 mg/day) and intravenous tranexamic acid during ACL reconstruction surgery (1 gram of iv TXA just prior to incision and 1 gram of iv TXA just prior to wound closure)

Group II: Placebo Placebo Group 1 Intervention

5-day course of placebo and intravenous saline during ACL reconstruction surgery

Tranexamic Acid is already approved in United States, European Union, Canada, Japan for the following indications:

Approved in United States as Tranexamic Acid for:

• Heavy menstrual bleeding
• Prevention of excessive bleeding during surgeries

Approved in European Union as Tranexamic Acid for:

• Heavy menstrual bleeding
• Prevention of excessive bleeding during surgeries
• Hereditary angioedema

Approved in Canada as Tranexamic Acid for:

• Heavy menstrual bleeding
• Prevention of excessive bleeding during surgeries

Approved in Japan as Tranexamic Acid for:

• Heavy menstrual bleeding
• Prevention of excessive bleeding during surgeries

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials

2,527

Recruited

17,430,000+

United States Department of Defense

Collaborator

Trials

940

Recruited

339,000+

Published Research Related to This Trial

A meta-analysis of 28 randomized controlled trials involving 4,200 participants found that combined administration of tranexamic acid (TXA) significantly reduces total blood loss and postoperative hemoglobin drop compared to using TXA through a single route (oral, intravenous, or topical).

Oral administration of TXA showed similar efficacy to intravenous or topical routes, indicating that it can be an effective alternative for reducing blood loss in total knee arthroplasty.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

What is the ideal route of administration of tranexamic acid in total knee arthroplasty? A meta-analysis based on randomized controlled trials. Lu, F., Sun, X., Wang, W., et al.[2021]

A study of 248 patient injury claims related to ACL reconstruction in Finland revealed that the most common complications leading to compensation were deep surgical site infections (DSSI) and malposition of the graft tunnel, particularly on the femoral side.

Improving surgical techniques and focusing on infection prevention could significantly reduce the occurrence of serious complications following ACL reconstruction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Anterior cruciate ligament reconstruction-related patient injuries: a nationwide registry study in Finland. Nyrhinen, KM., Bister, V., Helkamaa, T., et al.[2020]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12509242/

Intra‑articular tranexamic acid improves 1‑ and 3‑month ... Multiple randomised clinical trials (RCTs) have suggested that TXA can reduce hemarthrosis, swelling, postoperative pain and improve function ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT03552705

The Effects of Tranexamic Acid on Joint Inflammation and ... This study will determine whether treatment with Tranexamic Acid (TXA), an FDA approved medication that reduces bleeding right after ACL injury and ...

3. withpower.com withpower.com/trial/phase-3-inflammation-7-2019-e0f5c

Tranexamic Acid for Post-ACL Injury Arthritis Tranexamic Acid (TXA) is known to reduce bleeding in joint surgeries, which can help minimize complications like excessive bleeding during ACL reconstruction, ...

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

801 - association of tranexamic acid during anterior ... The purpose of our study is to assess the association of TXA on inflammation, chondral health and knee function 6 months after ACLR.

5. ortho.stanford.edu ortho.stanford.edu/research/clinical-trials.html

Clinical Trials | Department of Orthopaedic Surgery This study will determine whether treatment with Tranexamic Acid (TXA), an FDA approved medication that reduces bleeding right after ACL injury and ...

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

Tranexamic Acid Use in Anterior Cruciate Ligament ... Tranexamic acid use in anterior cruciate ligament reconstruction decreases bleeding complications: a systematic review and meta-analysis of randomized ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8801653/

Administration of Tranexamic Acid to Reduce Intra-articular ... The current best available evidence suggests that TXA administration at the time of ACLR results in decreased intra-articular bleeding.

8. journals.lww.com journals.lww.com/jbjsjournal/fulltext/2024/02070/in_vivo_effect_of_single_intra_articular_injection.8.aspx

In Vivo Effect of Single Intra-Articular Injection of... : JBJS In a study by Chiang et al., intra-articular injection (100 mg/mL) of TXA in patients undergoing ACL reconstruction resulted in decreased pain ...