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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Polyp, Colorectal

Intervention / Treatment
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* Drug: Tranexamic Acid Injection [Cyklokapron]


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients aged over 18 who have non-pedunculated colorectal polyps, Polyps ≥2cm, Polyps removed by endoscopic mucosal resection (EMR), Agree to be followed up by phone, Ability to read and understand the English language. Exclusion Criteria: Patients who have inflammatory bowel disease, Diagnosed bleeding disorder, Ulcerated morphology of polyps or those with proven invasive cancer, 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), Unable to provide follow up, Unable to provide consent, Pregnancy, Patients undergoing endoscopic submucosal dissection (ESD), Seizure disorder, Ureteral obstruction within past 6 months, Subarachnoid hemorrhage within past 6 months, A diagnosed acquired defective colour vision disorder.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Interventional 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).
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tranexamic Acid<br>Intra-procedural tranexamic acid (TXA) - 1 gram, IV Post-procedural tranexamic acid (TXA) - 1 gram, oral, three times per day for 5 days | Drug: Tranexamic Acid Injection [Cyklokapron]<br>* 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.<br>* Other names: Tranexamic Acid Oral Tablets [Cyklokapron];|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Enrollment frequency | How many participants are enrolled each week | Through study completion, an average of 6 months | 
| Study drug compliance rates | Number of participants that receive the intravenous tranexamic acid within 2 hours of polyp removal and the number of participants that receive every scheduled dose of the tranexamic acid at home | Through study completion, an average of 6 months | 
| Recruitment rates | How many eligible patients decide to participate in the study | Through study completion, an average of 6 months | 
| Follow-up rates | How many participants complete all follow-up phone calls | Through study completion, an average of 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events | How many participants experience thromboembolic events, perforation and post-polypectomy electrocoagulation syndrome, seizure activity and vision changes | Up to 30 days | 
| Post-procedure bleeding | How many participants experience severe bleeding event that requires hospitalization, transfusion, colonoscopy, surgery or another invasive intervention within 30 days after completion of the colonoscopy with polypectomy | Up to 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Endoscopic Mucosal Resection (EMR), Tranexamic Acid, Colonoscopy