Polyp, Colorectal Clinical Trial
Official title:
Tranexamic Acid to Prevent Bleeding After Endoscopic Resection of Large Colorectal Polyps: A Pilot Project
| Verified date | April 2024 |
| Source | Queen's University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 25 |
| Est. completion date | April 1, 2023 |
| Est. primary completion date | October 10, 2021 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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. |
| Country | Name | City | State |
|---|---|---|---|
| Canada | Kingston Health Sciences Centre - Hotel Dieu Hospital Site | Kingston | Ontario |
| Lead Sponsor | Collaborator |
|---|---|
| Lawrence Charles Hookey | Queen's University |
Canada,
Albeniz E, Alvarez MA, Espinos JC, Nogales O, Guarner C, Alonso P, Rodriguez-Tellez M, Herreros de Tejada A, Santiago J, Bustamante-Balen M, Rodriguez Sanchez J, Ramos-Zabala F, Valdivielso E, Martinez-Alcala F, Fraile M, Elosua A, Guerra Veloz MF, Ibanez — View Citation
Albeniz E, Fraile M, Ibanez B, Alonso-Aguirre P, Martinez-Ares D, Soto S, Gargallo CJ, Ramos Zabala F, Alvarez MA, Rodriguez-Sanchez J, Mugica F, Nogales O, Herreros de Tejada A, Redondo E, Pin N, Leon-Brito H, Pardeiro R, Lopez-Roses L, Rodriguez-Tellez — View Citation
ASGE Standards of Practice Committee; Fisher DA, Maple JT, Ben-Menachem T, Cash BD, Decker GA, Early DS, Evans JA, Fanelli RD, Fukami N, Hwang JH, Jain R, Jue TL, Khan KM, Malpas PM, Sharaf RN, Shergill AK, Dominitz JA. Complications of colonoscopy. Gastr — View Citation
Bennett C, Klingenberg SL, Langholz E, Gluud LL. Tranexamic acid for upper gastrointestinal bleeding. Cochrane Database Syst Rev. 2014 Nov 21;2014(11):CD006640. doi: 10.1002/14651858.CD006640.pub3. — View Citation
Burgess NG, Metz AJ, Williams SJ, Singh R, Tam W, Hourigan LF, Zanati SA, Brown GJ, Sonson R, Bourke MJ. Risk factors for intraprocedural and clinically significant delayed bleeding after wide-field endoscopic mucosal resection of large colonic lesions. C — View Citation
Feagins LA. Colonoscopy, Polypectomy, and the Risk of Bleeding. Med Clin North Am. 2019 Jan;103(1):125-135. doi: 10.1016/j.mcna.2018.08.003. Epub 2018 Nov 1. — View Citation
Forbes N, Frehlich L, James MT, Hilsden RJ, Kaplan GG, Wilson TA, Lorenzetti DL, Tate DJ, Bourke MJ, Heitman SJ. Routine Prophylactic Endoscopic Clipping Is Not Efficacious in the Prevention of Delayed Post-Polypectomy Bleeding: A Systematic Review and Me — View Citation
Grass F, Braafladt S, Alabbad J, Lovely JK, Kelley SR, Mathis KL, Huebner M, Larson DW. The effects of tranexamic acid on blood loss and transfusion rate in colorectal surgery. Am J Surg. 2019 Nov;218(5):876-880. doi: 10.1016/j.amjsurg.2019.03.013. Epub 2 — View Citation
Hassan C, Repici A, Sharma P, Correale L, Zullo A, Bretthauer M, Senore C, Spada C, Bellisario C, Bhandari P, Rex DK. Efficacy and safety of endoscopic resection of large colorectal polyps: a systematic review and meta-analysis. Gut. 2016 May;65(5):806-20 — View Citation
Nishihara R, Wu K, Lochhead P, Morikawa T, Liao X, Qian ZR, Inamura K, Kim SA, Kuchiba A, Yamauchi M, Imamura Y, Willett WC, Rosner BA, Fuchs CS, Giovannucci E, Ogino S, Chan AT. Long-term colorectal-cancer incidence and mortality after lower endoscopy. N — View Citation
Pohl H, Grimm IS, Moyer MT, Hasan MK, Pleskow D, Elmunzer BJ, Khashab MA, Sanaei O, Al-Kawas FH, Gordon SR, Mathew A, Levenick JM, Aslanian HR, Antaki F, von Renteln D, Crockett SD, Rastogi A, Gill JA, Law RJ, Elias PA, Pellise M, Wallace MB, Mackenzie TA — View Citation
Roberts I, Shakur H, Coats T, Hunt B, Balogun E, Barnetson L, Cook L, Kawahara T, Perel P, Prieto-Merino D, Ramos M, Cairns J, Guerriero C. The CRASH-2 trial: a randomised controlled trial and economic evaluation of the effects of tranexamic acid on death — View Citation
Smith SR, Murray D, Pockney PG, Bendinelli C, Draganic BD, Carroll R. Tranexamic Acid for Lower GI Hemorrhage: A Randomized Placebo-Controlled Clinical Trial. Dis Colon Rectum. 2018 Jan;61(1):99-106. doi: 10.1097/DCR.0000000000000943. — View Citation
WOMAN Trial Collaborators. Effect of early tranexamic acid administration on mortality, hysterectomy, and other morbidities in women with post-partum haemorrhage (WOMAN): an international, randomised, double-blind, placebo-controlled trial. Lancet. 2017 M — View Citation
* Note: There are 14 references in all — Click here to view all references
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Enrollment frequency | How many participants are enrolled each week | Through study completion, an average of 6 months | |
| Primary | 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 | |
| Primary | Recruitment rates | How many eligible patients decide to participate in the study | Through study completion, an average of 6 months | |
| Primary | Follow-up rates | How many participants complete all follow-up phone calls | Through study completion, an average of 6 months | |
| Secondary | Adverse events | How many participants experience thromboembolic events, perforation and post-polypectomy electrocoagulation syndrome, seizure activity and vision changes | Up to 30 days | |
| Secondary | 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 |