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Anti-fibrinolytic agent

Topical TRanexamic Acid for Distal Radius Fracture (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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 hours to 72 hours postoperatively

Awards & highlights

TRADR 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.Check my eligibility

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.See study design

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.

TRADR Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am 18 years old or older.

Select...

I am having surgery for a wrist fracture using the volar approach.

TRADR Trial 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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 hours to 72 hours postoperatively for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

acute post-op pain

Secondary outcome measures

Patient reported function

opioid use

persistent pain

+1 more

Side effects data

From 2017 Phase 4 trial • 246 Patients • NCT02030821

Deep Infection

Superficial Cellulitis

Hematoma/Seroma

100%

80%

60%

40%

20%

Study treatment Arm

Tranexamic Acid (TXA) - Total Hip Arthroplasty

Epsilon-aminocaproic Acid (Amicar) - Total Hip Arthroplasty

Epsilon-aminocaproic Acid (Amicar) - Total Knee Arthroplasty

Tranexamic Acid (TXA) - Total Knee Arthroplasty

TRADR 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

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

University Health Network, TorontoLead Sponsor

1,478 Previous Clinical Trials

485,310 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any vacancies available for patients to participate in this trial?

"As per clinicaltrials.gov, the ongoing trial in question is not currently seeking participants. It was initially listed on August 1st, 2024, with the latest update dated April 22nd, 2024. Although this specific study is not recruiting volunteers presently, there are a substantial number of other trials actively searching for participants - totaling to be around 868."

Answered by AI

What are the safety considerations for individuals using topical tranexamic acid?

"On a scale of 1 to 3, with 3 indicating the highest safety level, our team at Power rates Topical Tranexamic Acid as a 3 due to its Phase IV status signifying approval for use."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Topical TRanexamic Acid vs. Placebo on Acute Postoperative Pain Following DRF Fixation

Ryan Paul 2024. "Topical TRanexamic Acid vs. Placebo on Acute Postoperative Pain Following DRF Fixation". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06384456.

All > Acute Pain