Tranexamic Acid for Anterior Cruciate Ligament Injury
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.12345Why 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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive oral TXA or placebo for 8 days post-surgery, along with standard IV TXA during surgery
Follow-up
Participants are monitored for pain, motion, strength, and function at multiple intervals post-surgery
Long-term follow-up
Participants complete a survey to assess long-term outcomes
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
Oral TXA 1.95 g (three 650 mg capsules) once daily, POD 0 through POD 7 (8 doses, 24 capsules), in addition to standard IV TXA 1 g before incision and 1 g at closure and the standardized postoperative regimen.
Three matching microcrystalline cellulose capsules once daily, POD 0 through POD 7 (24 capsules), in addition to standard IV TXA 1 g before incision and 1 g at closure and the standardized postoperative regimen.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Dave Bernholt
Lead Sponsor
American Orthopaedic Society for Sports Medicine
Collaborator
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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