CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 25 enrolled
Drug / intervention
Tranexamic Acid Injection [Cyklokapron]drug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04559880
NCT04559880Phase 4Completed

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

Lawrence Charles Hookey·interventional·Posted Sep 23, 2020·Updated Apr 3, 2024

In Brief

A Phase 4 clinical trial evaluating Tranexamic Acid Injection [Cyklokapron] for Polyp, Colorectal. Completed, enrolled 25 participants across 1 site.

Detailed Summary

Colorectal cancer is the second most common cancer in Canada. Colonoscopy and removal of precancerous polyps (polypectomy) reduces the incidence and mortality associated with colorectal cancer. However, polypectomy is associated with adverse events. Post-polypectomy bleeding has a significant impact on the life of the patient as it can require hospitalization, transfusions, repeat colonoscopy and rarely death. It is also a substantial cost to the health care system. There currently is no standard of care to prevent bleeding after polypectomy. Tranexamic acid reduces fibrinolysis by slowing down the conversion of plasminogen to plasmin which may prevent bleeding. Although this medication is used extensively for other purposes, it has not been studied before to prevent post-polypectomy bleeding. This pilot study will examine factors involved in the feasibility of conducting a large-scale randomized controlled trial (RCT). This pilot study will include 25 consecutive patients who are treated with tranexamic acid after endoscopic mucosal resection (EMR) of large non-pedunculated colorectal polyps (LNPCP's) to prevent PPDB.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesCanada
CollaboratorsQueen's University

Timeline

Phase 4CompletedFinished
202120222023202420252026
First PostedSep 23, 2020
Enrollment StartSep 10, 2020
Primary CompletionOct 10, 2021
Study CompletionApr 1, 2023
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 5.8 years ago

Interventions

Tranexamic Acid Injection [Cyklokapron]drug

Intra-procedurally, participants will receive 1 gram of intravenous tranexamic acid immediately following the polypectomy. Participants will also take oral tranexamic acid tablets (three times per day) at home for the five days following the procedure.