Tranexamic Acid for Anterior Cruciate Ligament Injury

Not yet recruiting at 5 trial locations
RM
Overseen ByResearch Manager
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether taking oral tranexamic acid (TXA) for a week after ACL surgery aids recovery. Researchers aim to determine if TXA can reduce knee pain, decrease the need for opioid pain medication, and improve knee movement two weeks post-surgery. Participants will receive either TXA or a placebo (a pill with no active drug) and will record pain and medication use in a diary. The trial targets individuals aged 14 to 25 undergoing ACL surgery with a specific type of graft and who meet certain health criteria. As a Phase 3 trial, it represents the final step before FDA approval, allowing participants to contribute to the potential approval of a new treatment.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Previous studies have shown that tranexamic acid (TXA) is well-tolerated by many people. The FDA has approved it to reduce bleeding during surgeries, indicating its general safety for that use. Many patients who have taken TXA report only mild side effects, such as nausea or diarrhea, with serious side effects being very rare.

As a phase 3 trial, TXA has already undergone earlier testing stages to assess its safety in humans. This phase focuses more on its effectiveness, as its safety has been reasonably established. For those considering joining this trial, it is reassuring that TXA has a history of safety for many people.12345

Why do researchers think this study treatment might be promising?

Tranexamic Acid (TXA) is unique because it takes a proactive approach to managing bleeding in patients undergoing surgery for anterior cruciate ligament (ACL) injuries. Unlike traditional treatments that may only address bleeding after it starts, TXA works by preventing excessive bleeding from the get-go. The combination of oral and IV administration ensures that the medication is active both before and after the surgical procedure, potentially leading to better outcomes and faster recovery times. Researchers are excited about TXA because it could enhance surgical safety and efficiency by minimizing blood loss and reducing the need for blood transfusions.

What evidence suggests that oral tranexamic acid is effective for ACL injury recovery?

Research has shown that tranexamic acid (TXA) can be very helpful after ACL surgery. In this trial, participants will receive either oral TXA or a placebo, in addition to standard IV TXA. Studies indicate that TXA reduces bleeding, swelling, and pain in the knee. It also seems to improve knee mobility and aid in removing excess fluid after surgery. Patients who received TXA reported less pain and required fewer pain medications early on. This suggests that TXA might help speed up recovery and improve knee function after ACL surgery.678910

Are You a Good Fit for This Trial?

This trial is for adolescents and young adults aged 14 to 25 who are having ACL reconstruction surgery. Participants must be able to take oral medication after surgery. People with certain medical conditions or allergies may not be eligible.

Inclusion Criteria

Weight of at least 100 lbs (45.4 kg)
Fluent in English
My knee growth plates are nearly closed with less than 1 year of growth left.
See 1 more

Exclusion Criteria

I have had seizures in the past.
I have had a blood clot or similar event in the past.
I am having a repeat or complex knee ligament surgery.
See 5 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive oral TXA or placebo for 8 days post-surgery, along with standard IV TXA during surgery

1 week
Daily self-administration

Follow-up

Participants are monitored for pain, motion, strength, and function at multiple intervals post-surgery

1 year
Visits at 2 weeks, 6 weeks, 12 weeks, 6 months, 9 months, and 1 year

Long-term follow-up

Participants complete a survey to assess long-term outcomes

2 years
Survey at 2 years

What Are the Treatments Tested in This Trial?

Interventions

  • Tranexamic Acid

Trial Overview

The study compares taking oral tranexamic acid (TXA) daily for one week after ACL surgery versus a placebo, in addition to standard care. It aims to see if TXA helps reduce pain, opioid use, and improves knee recovery.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Placebo Group

Group I: Oral TXAExperimental Treatment1 Intervention
Group II: PlaceboPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Dave Bernholt

Lead Sponsor

American Orthopaedic Society for Sports Medicine

Collaborator

Trials
8
Recruited
2,100+

Citations

Meta-Analysis Tranexamic Acid Use in Anterior Cruciate ...

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.

The Efficacy of Tranexamic Acid in Anterior Cruciate ...

The TXA group demonstrated significantly better drainage output, pain scores, and ROM in the early postoperative period.

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.

The advantages of using tranexamic acid in anterior ...

IA injection of TXA effectively reduces post-operative blood loss. The ap- plication of TXA significantly reduced post-operative bleeding and pain intensity, ...

Extended Oral Tranexamic Acid After Anterior Cruciate ...

This trial aims to investigate whether a 10-day postoperative course of oral TXA improves pain and recovery outcomes following ACLR.

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