Polyp, ColorectalPhase 4NCT04559880
Tranexamic Acid to Prevent Bleeding After Endoscopic Resection of Large Colorectal Polyps: A Pilot Project
A Phase 4 study testing Tranexamic Acid Injection [Cyklokapron] in people with Polyp, Colorectal, run by Lawrence Charles Hookey at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Polyp, Colorectal
- What is being tested?
- Tranexamic Acid Injection [Cyklokapron]
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteCanada
- Study dates
- 10 Sep 2020to 1 Apr 2023
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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,
Show all 12Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Kingston Health Sciences Centre - Hotel Dieu Hospital Site
Kingston, Ontario, K7L 5G2
About this study
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.
Read the 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.
- Conditions
- Polyp, Colorectal
- Being tested
- Tranexamic Acid Injection [Cyklokapron]
- Keywords
- Endoscopic Mucosal Resection (EMR), Tranexamic Acid, Colonoscopy
- Medical subject headings
- Polyps
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tranexamic Acid Injection [Cyklokapron]Drug
Also called Tranexamic Acid Oral Tablets [Cyklokapron]
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.
| Study group | Role | What they receive |
|---|---|---|
| Tranexamic Acid | Experimental | Intra-procedural tranexamic acid (TXA) - 1 gram, IV
Post-procedural tranexamic acid (TXA) - 1 gram, oral, three times per day for 5 days Receives: Drug: Tranexamic Acid Injection [Cyklokapron] |
What is being measured
The primary outcome is the main question the study is designed to answer.
Enrollment frequency
How many participants are enrolled each week
Measured: 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
Measured: Through study completion, an average of 6 months
Recruitment rates
How many eligible patients decide to participate in the study
Measured: Through study completion, an average of 6 months
Follow-up rates
How many participants complete all follow-up phone calls
Measured: Through study completion, an average of 6 months
Secondary outcomes (2)
Adverse events
How many participants experience thromboembolic events, perforation and post-polypectomy electrocoagulation syndrome, seizure activity and vision changes
Measured: 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
Measured: Up to 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2020
- Study start10 Sep 2020
- Primary completion10 Oct 2021
- Study completion1 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Polyp, ColorectalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lawrence Charles Hookey
- Sponsor type
- University, hospital or other
- Collaborators
- Queen's University
- Responsible party
- Sponsor-investigator, Lawrence Charles Hookey, Queen's University
- Investigators
- Robert Bechara, MD, Principal investigator, Queen's University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04559880
- Sponsor's protocol ID
- 6029804
- Status last verified
- Apr 2024
- First submitted
- 10 Sep 2020
- Last updated
- 3 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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 Engl J Med. 2013 Sep 19;369(12):1095-105. doi: 10.1056/NEJMoa1301969.
PubMed 24047059ASGE 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. Gastrointest Endosc. 2011 Oct;74(4):745-52. doi: 10.1016/j.gie.2011.07.025. No abstract available.
PubMed 21951473Albeniz 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 M, Jimenez A, Martinez-Alcala F, Garcia O, de la Pena J, Ono A, Alberca de Las Parras F, Pellise M, Rivero L, Saperas E, Perez-Roldan F, Pueyo Royo A, Eguaras Ros J, Zuniga Ripa A, Concepcion-Martin M, Huelin-Alvarez P, Colan-Hernandez J, Cubiella J, Remedios D, Bessa I Caserras X, Lopez-Viedma B, Cobian J, Gonzalez-Haba M, Santiago J, Martinez-Cara JG, Valdivielso E, Guarner-Argente C; Endoscopic Mucosal Resection Endoscopic Spanish Society Group. A Scoring System to Determine Risk of Delayed Bleeding After Endoscopic Mucosal Resection of Large Colorectal Lesions. Clin Gastroenterol Hepatol. 2016 Aug;14(8):1140-7. doi: 10.1016/j.cgh.2016.03.021. Epub 2016 Mar 24.
PubMed 27033428Pohl 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, Rex DK. Clip Closure Prevents Bleeding After Endoscopic Resection of Large Colon Polyps in a Randomized Trial. Gastroenterology. 2019 Oct;157(4):977-984.e3. doi: 10.1053/j.gastro.2019.03.019. Epub 2019 Mar 15.
PubMed 30885778Feagins 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.
PubMed 30466669Hassan 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. doi: 10.1136/gutjnl-2014-308481. Epub 2015 Feb 13.
PubMed 25681402Burgess 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. Clin Gastroenterol Hepatol. 2014 Apr;12(4):651-61.e1-3. doi: 10.1016/j.cgh.2013.09.049. Epub 2013 Oct 1.
PubMed 24090728Forbes 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 Meta-Analysis of Randomized Controlled Trials. J Can Assoc Gastroenterol. 2019 Aug;2(3):105-117. doi: 10.1093/jcag/gwy033. Epub 2018 Jul 20.
PubMed 31294373Albeniz 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 Beroiz B, Capdevila F, Enguita-German M. Clip Closure After Resection of Large Colorectal Lesions With Substantial Risk of Bleeding. Gastroenterology. 2019 Nov;157(5):1213-1221.e4. doi: 10.1053/j.gastro.2019.07.037. Epub 2019 Jul 27.
PubMed 31362007Roberts 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, vascular occlusive events and transfusion requirement in bleeding trauma patients. Health Technol Assess. 2013 Mar;17(10):1-79. doi: 10.3310/hta17100.
PubMed 23477634WOMAN 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 May 27;389(10084):2105-2116. doi: 10.1016/S0140-6736(17)30638-4. Epub 2017 Apr 26.
PubMed 28456509Bennett 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.
PubMed 25414987Smith 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.
PubMed 29215478Grass 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 2019 Mar 15.
PubMed 30926155
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tranexamic Acid to Prevent Bleeding After Endoscopic Resection of Large Colorectal Polyps: A Pilot Project
- ClinicalTrials.gov ID
- NCT04559880
- Acronym / sponsor ID
- 6029804
- Conditions
- Polyp, Colorectal
- Keywords
- Endoscopic Mucosal Resection (EMR), Tranexamic Acid, Colonoscopy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Lawrence Charles HookeyUniversity, hospital or other
- Collaborators
- Queen's University
- Study start
- 10 Sep 2020 (actual)
- Primary completion
- 10 Oct 2021 (actual)
- Study completion
- 1 Apr 2023 (actual)
- First posted
- 23 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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).
| Arm | Type | Receives |
|---|---|---|
| Tranexamic Acid | Experimental | Drug: 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (12 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tranexamic Acid Injection [Cyklokapron]Also: Tranexamic Acid Oral Tablets [Cyklokapron]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. | Drug | Tranexamic Acid |
Primary outcome
Enrollment frequency
Time frame: Through study completion, an average of 6 months
How many participants are enrolled each week
Study drug compliance rates
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
Recruitment rates
Time frame: Through study completion, an average of 6 months
How many eligible patients decide to participate in the study
Follow-up rates
Time frame: Through study completion, an average of 6 months
How many participants complete all follow-up phone calls
2 secondary outcomes
Adverse events
Time frame: Up to 30 days
Post-procedure bleeding
Time frame: Up to 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2024.
- Results publication: PubMed 24047059Nishihara 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 Engl J Med. 2013 Sep 19;369(12):1095-105. doi: 10.1056/NEJMoa1301969.
- Results publication: PubMed 21951473ASGE 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. Gastrointest Endosc. 2011 Oct;74(4):745-52. doi: 10.1016/j.gie.2011.07.025. No abstract available.
- Results publication: PubMed 27033428Albeniz 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 M, Jimenez A, Martinez-Alcala F, Garcia O, de la Pena J, Ono A, Alberca de Las Parras F, Pellise M, Rivero L, Saperas E, Perez-Roldan F, Pueyo Royo A, Eguaras Ros J, Zuniga Ripa A, Concepcion-Martin M, Huelin-Alvarez P, Colan-Hernandez J, Cubiella J, Remedios D, Bessa I Caserras X, Lopez-Viedma B, Cobian J, Gonzalez-Haba M, Santiago J, Martinez-Cara JG, Valdivielso E, Guarner-Argente C; Endoscopic Mucosal Resection Endoscopic Spanish Society Group. A Scoring System to Determine Risk of Delayed Bleeding After Endoscopic Mucosal Resection of Large Colorectal Lesions. Clin Gastroenterol Hepatol. 2016 Aug;14(8):1140-7. doi: 10.1016/j.cgh.2016.03.021. Epub 2016 Mar 24.
- Results publication: PubMed 30885778Pohl 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, Rex DK. Clip Closure Prevents Bleeding After Endoscopic Resection of Large Colon Polyps in a Randomized Trial. Gastroenterology. 2019 Oct;157(4):977-984.e3. doi: 10.1053/j.gastro.2019.03.019. Epub 2019 Mar 15.
- Results publication: PubMed 30466669Feagins 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.
- Results publication: PubMed 25681402Hassan 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. doi: 10.1136/gutjnl-2014-308481. Epub 2015 Feb 13.
- Results publication: PubMed 24090728Burgess 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. Clin Gastroenterol Hepatol. 2014 Apr;12(4):651-61.e1-3. doi: 10.1016/j.cgh.2013.09.049. Epub 2013 Oct 1.
- Results publication: PubMed 31294373Forbes 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 Meta-Analysis of Randomized Controlled Trials. J Can Assoc Gastroenterol. 2019 Aug;2(3):105-117. doi: 10.1093/jcag/gwy033. Epub 2018 Jul 20.
- Results publication: PubMed 31362007Albeniz 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 Beroiz B, Capdevila F, Enguita-German M. Clip Closure After Resection of Large Colorectal Lesions With Substantial Risk of Bleeding. Gastroenterology. 2019 Nov;157(5):1213-1221.e4. doi: 10.1053/j.gastro.2019.07.037. Epub 2019 Jul 27.
- Results publication: PubMed 23477634Roberts 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, vascular occlusive events and transfusion requirement in bleeding trauma patients. Health Technol Assess. 2013 Mar;17(10):1-79. doi: 10.3310/hta17100.
- Results publication: PubMed 28456509WOMAN 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 May 27;389(10084):2105-2116. doi: 10.1016/S0140-6736(17)30638-4. Epub 2017 Apr 26.
- Results publication: PubMed 25414987Bennett 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert Bechara, MD principal investigator
Queen's University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Tranexamic Acid Injection [Cyklokapron] in people with Polyp, Colorectal, run by Lawrence Charles Hookey at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Enrollment frequency (time frame: Through study completion, an average of 6 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04559880, which also lists 14 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2024.