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Tranexamic Acid for Polyp Bleeding Prevention

Phase 4

Waitlist Available

Led By Robert Bechara, MD

Research Sponsored by Lawrence Charles Hookey

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Polyps removed by endoscopic mucosal resection (EMR)

Patients aged over 18 who have non-pedunculated colorectal polyps

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, an average of 6 months

Awards & highlights

Study Summary

This trial will investigate whether using tranexamic acid can reduce post-polypectomy bleeding, a cause of hospitalization and potentially death.

Who is the study for?

This trial is for adults over 18 with large, non-pedunculated colorectal polyps (≥2cm) removed by EMR. Participants must be able to follow up by phone and understand English. It's not specified who can't join.Check my eligibility

What is being tested?

The study tests Tranexamic Acid Injection [Cyklokapron] to prevent bleeding after removing large colorectal polyps via endoscopy. This pilot will help determine if a larger trial is feasible, involving 25 patients treated post-EMR.See study design

What are the potential side effects?

While specific side effects are not listed for this trial, Tranexamic Acid generally may cause nausea, diarrhea, vomiting or allergic reactions in some individuals.

Eligibility Criteria

Inclusion Criteria

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

Select...

I had polyps removed from my gut using a special scope.

Select...

I am over 18 and have non-pedunculated colorectal polyps.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, an average of 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion, an average of 6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 6 months for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Enrollment frequency

Follow-up rates

Recruitment rates

+1 more

Secondary outcome measures

Adverse events

Post-procedure bleeding

Side effects data

From 2017 Phase 4 trial • 246 Patients • NCT02030821

Hematoma/Seroma

100%

80%

60%

40%

20%

Study treatment Arm

Epsilon-aminocaproic Acid (Amicar) - Total Hip Arthroplasty

Epsilon-aminocaproic Acid (Amicar) - Total Knee Arthroplasty

Tranexamic Acid (TXA) - Total Hip Arthroplasty

Tranexamic Acid (TXA) - Total Knee Arthroplasty

Trial Design

1Treatment groups

Experimental Treatment

Group I: Tranexamic AcidExperimental Treatment1 Intervention

Intra-procedural tranexamic acid (TXA) - 1 gram, IV Post-procedural tranexamic acid (TXA) - 1 gram, oral, three times per day for 5 days

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Tranexamic acid

FDA approved

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Lawrence Charles HookeyLead Sponsor

6 Previous Clinical Trials

1,662 Total Patients Enrolled

Queen's UniversityOTHER

365 Previous Clinical Trials

120,392 Total Patients Enrolled

Robert Bechara, MDPrincipal InvestigatorQueen's University

1 Previous Clinical Trials

538 Total Patients Enrolled

Media Library

Tranexamic Acid Clinical Trial Eligibility Overview. Trial Name: NCT04559880 — Phase 4

Colorectal Adenomas Research Study Groups: Tranexamic Acid

Colorectal Adenomas Clinical Trial 2023: Tranexamic Acid Highlights & Side Effects. Trial Name: NCT04559880 — Phase 4

Tranexamic Acid 2023 Treatment Timeline for Medical Study. Trial Name: NCT04559880 — Phase 4

Frequently Asked Questions

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

What medical conditions are ameliorated by the administration of Tranexamic Acid?

"Tranexamic Acid may be prescribed to treat hyperfibrinolysis, hemophilia, and other conditions where there is uncontrolled bleeding."

Answered by AI

What possible adverse effects might arise from utilizing Tranexamic Acid?

"The safety of Tranexamic Acid was assessed as a 3, reflecting its status as an approved treatment. This evaluation is based on the fact that this drug has passed Phase 4 trials."

Answered by AI

Are opportunities still available for individuals to participate in this research project?

"According to clinicaltrials.gov, this medical trial is no longer enrolling participants at this time; the study's initial posting was on September 10th 2020 and its last edit occured on April 29th 2023. Nevertheless, 137 other trials are currently seeking volunteers."

Answered by AI

Have any past experiments delved into the effects of Tranexamic Acid?

"Currently, 60 clinical trials assessing the efficacy of Tranexamic Acid are taking place with 27 in Phase 3. Camperdown, New South Wales is home to many of these studies but there are over 300 other sites conducting research around this medication."

Answered by AI

What is the numerical scope of participants in this trial?

"This trial is not accepting applications at this moment. It was initially published on September 10, 2020 and its details were most recently altered on April 29th 2023. Other opportunities to participate in medical studies exist; 77 trials are actively recruiting colorectal adenoma patients while 60 studies for Tranexamic Acid have opened their doors for enrollment."

Answered by AI

Recent research and studies

GastroenterologyJournal

Clip Closure Prevents Bleeding After Endoscopic Resection of Large Colon Polyps in a Randomized Trial

Pohl, Heiko, Ian S. Grimm, Matthew T. Moyer, Muhammad K. Hasan, Douglas Pleskow, B. Joseph Elmunzer, Mouen A. Khashab, et al.. 2019. “Clip Closure Prevents Bleeding After Endoscopic Resection of Large Colon Polyps in a Randomized Trial”. Gastroenterology. Elsevier BV. doi:10.1053/j.gastro.2019.03.019.

clinicaltrials.govStudy

Tranexamic Acid to Prevent Bleeding After Endoscopic Resection of Large Colorectal Polyps: A Pilot Project

Lawrence Charles Hookey 2020. "Tranexamic Acid to Prevent Bleeding After Endoscopic Resection of Large Colorectal Polyps: A Pilot Project". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04559880.