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Oral Tranexamic Acid After Knee Replacement Surgery

This study is looking at whether taking oral tranexamic acid (TXA) after total knee replacement surgery helps reduce pain. You might be able to join if you are between 18 and 89 years old and are having a total knee replacement at the Connecticut Joint Replacement Institute by one of the participating surgeons. The study will compare pain levels in people who receive oral TXA to those who receive a placebo (an inactive pill). Researchers will measure your pain using a Visual Analogue Scale (VAS) on specific days and weeks after your surgery, up to 12 weeks. The study is currently recruiting 80 participants.

Study design
This is a randomized controlled trial, meaning participants are randomly assigned to receive either oral tranexamic acid or a placebo. It is a double-blind study, so neither you nor your surgeon will know which treatment you are receiving.
What's involved
If you are in the experimental group, you will take 1.95 grams of oral tranexamic acid each morning for three days after surgery. If you are in the control group, you will take a placebo for three days after surgery. Pain scores, range of motion, opioid use, and walking ability will be evaluated at specific times up to 12 weeks after surgery.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 12 weeks after surgery to assess various outcomes.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06479161

Effects of Oral Tranexamic Acid Following Total Knee Arthroplasty

Recruiting
PHASE2Ages 18–89InterventionalTreatment
Matthew Grosso, MD
~80 participants
Updated 2024-12-13 on ClinicalTrials.gov
What's tested:Tranexamic acid

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Visual Analogue Scale (VAS) Pain scores
Measured over postoperative day (POD) 0, 1, 2, 3 (+/- 0 days) and weeks 1 (+/- 0 days), 2 (+/- 2 days), 6 and 12 (+/- 7 days).

Conditions

Postoperative Pain

Explore related trials

Osteoarthritis

Where it's being run

1 sites across 1 states
Connecticut1

Who to contact

Gina Panek, BS
[email protected]
860-714-4164
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

\- All patients undergoing either manual or robotic primary total knee arthroplasty (TKA)
Performed by participating Connecticut Joint Replacement Institute (CJRI) surgeons (Dr. Matthew Grosso, Dr. Robert McAllister, Dr. Chad Daniel, Dr. Eric Silverstein, Dr. Alex Dukas, Dr. Michael Joyce, Dr. Brett Wasserlauf).
Male and female patient age 18-89
Primary diagnosis of knee osteoarthritis

Exclusion

Revision TKA
No exclusion based on gender
Patients \<18 and \>89 years old
Exclusion for IV oral tranexamic acid (TXA):
TXA allergy - there are NO absolute contraindications for TXA use.
History of stent placed within one year of surgery - patient will receive topical TXA as an alternative.
Exclusion for oral TXA:
Chronic opioid use (opioid use within the 4 weeks prior to surgery)
Allergies to nonsteroidal Anti-inflammatory drugs (NSAIDs) and acetaminophen
Patients with clinically significant drug interactions
Pre-existing neuropathy
Current or previous venous thrombosis (DVT or venous stasis disease)
Immuno-compromised secondary to medical condition
Immune-suppressive medications, chemotherapy
Pregnancy, breast feeding
History of pain catastrophizing. Major depressive disorder
History of suspected or known addiction to or abuse of illicit drug(s), prescription medicine(s), or alcohol within the past 2 years.
Currently on a neuroleptic agent \[e.g., gabapentin, pregabalin (Lyrica), duloxetine (Cymbalta) etc.\].
Non-English speaking and reading patient populations
Any clinically significant event or condition uncovered during the surgery (e.g., excessive bleeding, acute sepsis) that, in the opinion of the investigator, renders the subject medically unstable or complicates the subject's post-operative course.

What this trial measures

  • Visual Analogue Scale (VAS) Pain scorespostoperative day (POD) 0, 1, 2, 3 (+/- 0 days) and weeks 1 (+/- 0 days), 2 (+/- 2 days), 6 and 12 (+/- 7 days).

    Patient reported pain score from 0 to 10 where 0 is no pain and 10 is the most pain. Higher scores are a worse outcome.