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Completed
NCT05169242
A Trial on Prophylactic Clipping to Prevent Post-polypectomy Bleeding After Colonoscopy in Direct Oral Anticoagulant Users
Conditions: Post Polypectomy Bleeding
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 584
Sponsor: Chinese University of Hong Kong
Location: Prince of Wales Hospital Shatin New Territories
Summary
The investigators hypothesize that prophylactic clipping after colonoscopic polypectomy can reduce risk of delayed PPB among DOAC users. The investigators also hypothesize that pre-endoscopy drug level can predict the risk of hemorrhagic complications after the procedure.
Eligibility 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
Source: ClinicalTrials.gov (NCT05169242). StuddyBuddy aggregates publicly available trial information.