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Anti-fibrinolytic agent
Topical Tranexamic Acid for Wrist Fractures (TRADR Trial)
Phase 4
Waitlist Available
Research Sponsored by University Health Network, Toronto
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Aged 18 or older
Patients undergoing open reduction internal fixation (Volar approach) for operative management of a distal radius fracture
Must not have
Known chronic pain conditions, fibromyalgia, or polymyalgia rheumatic
Distal radius fracture treated with a dorsal approach
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 hours to 72 hours postoperatively
Awards & highlights
Drug Has Already Been Approved
Pivotal Trial
Summary
"This trial aims to determine if applying a medication called topical tranexamic acid (TXA) directly to the surgical wound during wrist fracture surgery can reduce post-operative pain, decrease the need for pain medication
Who is the study for?
This trial is for individuals who are undergoing surgery for a wrist fracture. It aims to see if applying tranexamic acid (TXA) directly into the wound can reduce pain and improve wrist function post-surgery compared to a placebo.
What is being tested?
The study is testing topical tranexamic acid (TXA), applied to the surgical site, against a placebo. The focus is on measuring differences in post-operative pain, use of painkillers, and recovery of wrist function between the two groups.
What are the potential side effects?
While specific side effects aren't listed here, typical concerns with topical treatments may include local skin reactions like redness or itching at the application site.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
Select...
I am having surgery for a wrist fracture using the volar approach.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have a chronic pain condition, fibromyalgia, or polymyalgia rheumatica.
Select...
I had surgery on my wrist from the back of my hand.
Select...
I am currently using opioids regularly.
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I have had a stroke or clotting disorder like DVT or PE before.
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I have paralysis in my shoulder or arm due to a past nerve injury.
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I have had lymph nodes removed or have swelling in my arm or leg.
Select...
I have had or need more surgery on the same wrist that was injured.
Select...
I do not have severe heart or lung disease.
Select...
I haven't stopped my blood thinners as required before surgery.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 24 hours to 72 hours postoperatively
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 hours to 72 hours postoperatively
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
acute post-op pain
Secondary study objectives
Patient reported function
opioid use
persistent pain
+1 moreAwards & Highlights
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Topical TRanexamic AcidExperimental Treatment1 Intervention
10mL of 100mg/mL TXA in addition to the standard care
Group II: PlaceboPlacebo Group1 Intervention
10mL of 100mg/mL normal saline in addition to the standard care
Find a Location
Who is running the clinical trial?
University Health Network, TorontoLead Sponsor
1,531 Previous Clinical Trials
504,232 Total Patients Enrolled