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

Lawrence Charles Hookey

Status and phase: Completed; Phase 4

Conditions: Polyp, Colorectal

Treatments: Drug: Tranexamic Acid Injection [Cyklokapron]

Study type: Interventional

Funder types: Other

Identifiers

NCT04559880

6029804

Details and patient eligibility

About

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.

Full 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.

Enrollment: 25 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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25 participants in 1 patient group

Tranexamic Acid

Experimental group

Description:

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

Treatment:

Drug: Tranexamic Acid Injection [Cyklokapron]