Kingston Health Sciences Centre - Hotel Dieu Hospital Site
Kingston, Ontario, K7L 5G2, Canada
NCT Number: NCT04559880
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.
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Notify Me18 year and older
All sexes
Interventional
Phase 4
Kingston, Ontario, K7L 5G2, Canada
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Other names: Tranexamic Acid Oral Tablets [Cyklokapron]
Time frame: Through study completion, an average of 6 months
How many participants are enrolled each week
Time frame: 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
Time frame: Through study completion, an average of 6 months
How many eligible patients decide to participate in the study
Time frame: Through study completion, an average of 6 months
How many participants complete all follow-up phone calls
Time frame: Up to 30 days
How many participants experience thromboembolic events, perforation and post-polypectomy electrocoagulation syndrome, seizure activity and vision changes
Time frame: 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
Lawrence Charles Hookey
Other
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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