Preventing bleeding after polyp removal in patients using blood thinners
A Double Blinded Randomized Controlled Trial on Prophylactic Clipping to Prevent Post-polypectomy Bleeding After Colonoscopy in Direct Oral Anticoagulant Users
This study is testing if using special clips after removing polyps during a colonoscopy can help prevent bleeding in patients who take blood thinners.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 584 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Chinese University of Hong Kong Academic / other |
| Locations | 1 site (Shatin, New Territories) |
| Trial ID | NCT05169242 on ClinicalTrials.gov |
What this trial studies
This trial investigates whether using prophylactic clipping after colonoscopic polypectomy can reduce the risk of post-polypectomy bleeding (PPB) in patients who are on direct oral anticoagulants (DOACs). The study aims to determine if pre-endoscopy drug levels can predict the risk of bleeding complications following the procedure. Given the high risk of PPB in patients taking anticoagulants, this research seeks to provide clearer evidence on the efficacy of clipping as a preventive measure. The trial will include patients requiring elective colonoscopy for various indications, ensuring a focused approach to a high-risk group.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older who are active users of direct oral anticoagulants and require elective colonoscopy.
Not a fit: Patients with absolute contraindications to colonoscopy or those with severe comorbid conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly reduce the incidence of post-polypectomy bleeding in patients taking anticoagulants, improving patient safety and outcomes.
How similar studies have performed: While some studies have shown mixed results regarding the efficacy of prophylactic clipping, this trial focuses specifically on a high-risk group, making it a novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * They are active users of any DOAC * They require elective colonoscopy for colorectal cancer screening, polyp surveillance, or investigation of symptoms such as anemia or past gastrointestinal bleeding * Aged 18 years old or above; * Written informed consent obtained. Exclusion Criteria: * Absolute contraindications to colonoscopy * Any medical conditions precluding interruption of DOAC for procedure * Any medical conditions requiring concomitant uninterrupted dual antiplatelet drugs (single antiplatelet drug users will not be excluded) * Active gastrointestinal bleeding * Clinically significant bleeding tendency (decompensated cirrhosis or severe thrombocytopenia) * Severe renal impairment (defined as creatinine clearance \< 15 ml/min) * Pregnancy or lactation; * Advanced comorbid conditions (defined as American Society of Anesthesiologists grade 4 or above) * Unable to obtain informed consent
Where this trial is running
Shatin, New Territories
- Prince of Wales Hospital — Shatin, New Territories, Hong Kong (Recruiting)
Study contacts
- Study coordinator: Louis Ho Shing Lau
- Email: louishslau@cuhk.edu.lhk
- Phone: 35052211
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.