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

Phase 4

Completed

• Conditions: Polyp, Colorectal
• Interventions: Drug: Tranexamic Acid Injection [Cyklokapron]

• Registration Number: NCT04559880
• Lead Sponsor: Lawrence Charles Hookey

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.

Study Timeline

• Study Start: 2020-09-10
• Study First Submitted: 2020-09-10
• Study First Submitted QC: 2020-09-16
• Study First Posted: 2020-09-23
• Primary Completion: 2021-10-10
• Study Completion: 2023-04-01
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-02
• Last Update Posted: 2024-04-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Tranexamic Acid	Tranexamic Acid Injection [Cyklokapron]	Intra-procedural tranexamic acid (TXA) - 1 gram, IV Post-procedural tranexamic acid (TXA) - 1 gram, oral, three times per day for 5 days

Primary Outcome Measures

Name	Time	Method
Enrollment frequency	Through study completion, an average of 6 months	How many participants are enrolled each week
Recruitment rates	Through study completion, an average of 6 months	How many eligible patients decide to participate in the study
Follow-up rates	Through study completion, an average of 6 months	How many participants complete all follow-up phone calls
Study drug compliance rates	Through study completion, an average of 6 months	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

Secondary Outcome Measures

Name	Time	Method
Post-procedure bleeding	Up to 30 days	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
Adverse events	Up to 30 days	How many participants experience thromboembolic events, perforation and post-polypectomy electrocoagulation syndrome, seizure activity and vision changes

Trial Locations

Locations (1)

Kingston Health Sciences Centre - Hotel Dieu Hospital Site; 🇨🇦 Kingston, Ontario, Canada