Clinical trial NCT04559880: Tranexamic Acid to Prevent Bleeding After Endoscopic Resection of Large Colorectal Polyps: A Pilot Project
Official title: Tranexamic Acid to Prevent Bleeding After Endoscopic Resection of Large Colorectal Polyps: A Pilot Project
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Polyp, Colorectal
Keywords: Endoscopic Mucosal Resection (EMR)
Tranexamic Acid
Colonoscopy
Lead sponsor: Queen's University
Sponsor class: OTHER
Collaborators: name: Queen's University
First posted: 2020-09-23
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 25 consecutive patients treated with tranexamic acid after endoscopic mucosal resection (EMR) of large non-pedunculated colorectal polyps (LNPCP's) to prevent post-polypectomy delayed bleeding (PPDB).
Primary purpose: OTHER

Brief 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.

Detailed description: 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. Post-polypectomy delayed bleeding (PPDB) can occur up to a month following the procedure but is typically seen within the first week. Risk factors include the size of the polyp, antithrombotic or anticoagulation use, age, major comorbidities and proximal colon polyps. The incidence of bleeding after removal of large polyps is estimated to be around 2.6%-9.7%. 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.

This pilot study will examine factors involved in the feasibility of conducting a large-scale 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.

Eligibility criteria: Inclusion Criteria:

1. Patients aged over 18 who have non-pedunculated colorectal polyps,
2. Polyps ≥2cm,
3. Polyps removed by endoscopic mucosal resection (EMR),
4. Agree to be followed up by phone,
5. Ability to read and understand the English language.

Exclusion Criteria:

1. Patients who have inflammatory bowel disease,
2. Diagnosed bleeding disorder,
3. Ulcerated morphology of polyps or those with proven invasive cancer,
4. Patients with a history of or are at higher risk of thromboembolic events (atrial fibrillation on anticoagulation, history of stroke, transient ischemic attack (TIA), pulmonary embolism, deep vein thrombosis, hypercoagulable state, oral contraceptive pill (OCP) or hormone replacement therapy use, mechanical heart valve on anticoagulation, myocardial infarction in the last twelve months, retinal vein or retinal artery occlusion),
5. Unable to provide follow up,
6. Unable to provide consent,
7. Pregnancy,
8. Patients undergoing endoscopic submucosal dissection (ESD),
9. Seizure disorder,
10. Ureteral obstruction within past 6 months,
11. Subarachnoid hemorrhage within past 6 months,
12. A diagnosed acquired defective colour vision disorder.

Primary outcomes:
measure: Enrollment frequency
timeFrame: Through study completion, an average of 6 months
measure: Study drug compliance rates
timeFrame: Through study completion, an average of 6 months
measure: Recruitment rates
timeFrame: Through study completion, an average of 6 months
measure: Follow-up rates
timeFrame: Through study completion, an average of 6 months
Secondary outcomes:
measure: Adverse events
timeFrame: Up to 30 days
measure: Post-procedure bleeding
timeFrame: Up to 30 days
Other outcomes:
Locations:
city: Kingston
country: Canada
facility: Kingston Health Sciences Centre - Hotel Dieu Hospital Site
state: Ontario
Study officials:
affiliation: Queen's University
name: Robert Bechara, MD
role: PRINCIPAL_INVESTIGATOR
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