Tranexamic Acid for Post-ACL Injury Arthritis

Recruiting in Stanford (>99 mi)

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

Trial Summary

What is the purpose of this trial?

Patients who tear their ACL are at high risk for developing arthritis (post-traumatic osteoarthritis-PTOA) just 10 years later. Joint bleeding and inflammation contribute to deterioration of joint health. This study will determine whether treatment with Tranexamic Acid (TXA), an FDA approved medication that reduces bleeding right after ACL injury and reconstructive surgery reduces inflammation and improves joint health as a new strategy to prevent or delay the onset of PTOA.

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.

What data supports the effectiveness of the drug 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, although its effectiveness specifically for post-ACL injury arthritis is not well-documented. ^{1 2 3 4 5}

Is Tranexamic Acid (TXA) safe for use in humans?

Tranexamic Acid (TXA) is generally considered safe for use in humans, as it has been used in various medical conditions to reduce bleeding. However, specific safety data for its use in post-ACL injury arthritis is not available in the provided research articles. ^{6 7 8 9 10}

How is the drug Tranexamic Acid unique for treating post-ACL injury arthritis?

Tranexamic Acid (TXA) is unique because it is an antifibrinolytic agent, meaning it helps prevent the breakdown of blood clots, which can reduce bleeding and swelling in the joint after ACL surgery. While it is commonly used in surgeries like total knee arthroplasty to reduce blood loss, its use in ACL injuries is still being studied, particularly regarding the best method of administration, such as intravenous (IV) or intra-articular (IA) injection. ^{1 11 12 13 14}

Research Team

Constance Chu, MD

Principal Investigator

Stanford University

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Intra-articular Administration of Tranexamic Acid Has No Effect in Reducing Intra-articular Hemarthrosis and Postoperative Pain After Primary ACL Reconstruction Using a Quadruple Hamstring Graft: A Randomized Controlled Trial. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Administration of Tranexamic Acid to Reduce Intra-articular Hemarthrosis in ACL Reconstruction: A Systematic Review. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Tranexamic Acid Use in Anterior Cruciate Ligament Reconstruction Decreases Bleeding Complications: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Effect of tranexamic acid in arthroscopic anterior cruciate ligament repair: A systematic review and meta-analysis of randomised clinical trials. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Intra-articular Injection of Tranexamic Acid Reduced Postoperative Hemarthrosis in Arthroscopic Anterior Cruciate Ligament Reconstruction: A Prospective Randomized Study. [2020]

6. United States pubmed.ncbi.nlm.nih.gov

Tranexamic Acid Has No Effect on Postoperative Hemarthrosis or Pain Control After Anterior Cruciate Ligament Reconstruction Using Bone-Patellar Tendon-Bone Autograft: A Double-Blind, Randomized, Controlled Trial. [2021]

7. Sweden pubmed.ncbi.nlm.nih.gov

Anterior cruciate ligament reconstruction-related patient injuries: a nationwide registry study in Finland. [2020]

8. Sweden pubmed.ncbi.nlm.nih.gov

Compensation claims following anterior cruciate ligament injuries reported to the patient insurance company in Sweden in 2005-2014. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

Structural Consequences of a Partial Anterior Cruciate Ligament Injury on Remaining Joint Integrity: Evidence for Ligament and Bone Changes Over Time in an Ovine Model. [2021]

10. England pubmed.ncbi.nlm.nih.gov

Anterior cruciate ligament reconstruction as a day case with extended recovery. [2020]

11. China 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. [2021]

12. England pubmed.ncbi.nlm.nih.gov

Peri-articular administration of tranexamic acid is an alternative route in total knee arthroplasty: a systematic review and meta-analysis. [2022]

13. United States pubmed.ncbi.nlm.nih.gov

Intravenous vs Intra-Articular Tranexamic Acid in Total Knee Arthroplasty: A Randomized, Double-Blind Trial. [2018]

14. England pubmed.ncbi.nlm.nih.gov

The comparative efficacies of intravenous administration and intra-articular injection of tranexamic acid during anterior cruciate ligament reconstruction for reducing postoperative hemarthrosis: a prospective randomized study. [2021]