A Trial on Prophylactic Clipping to Prevent Post-polypectomy Bleeding After Colonoscopy in Direct Oral Anticoagulant Users

Recruiting now · Not applicable

Conditions studied: Post Polypectomy Bleeding

In brief

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.

Key facts

Study ID

NCT05169242

Run by

Chinese University of Hong Kong

People needed

584

Starts

2021-12-15

Expected to finish

2024-12-31

Last updated by the study team

2024-08-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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 it is running

• Prince of Wales Hospital — Shatin, New Territories, Hong Kong (enrolling)

Full record on ClinicalTrials.gov

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