Short-term interruption versus continuous anticoagulation in colorectal polypectomy. A randomized multicenter investigator-initiated non-inferiority clinical trial: the POLYPHEM trial.
- Conditions
- Patients receiving oral anticoagulant therapy who are scheduled for elective colonoscopy for any indication.Therapeutic area: Diseases [C] - Digestive System Diseases [C06]Therapeutic area: Analytical,Diagnostic,Therapeutic Techniques and Equipment [E]-Surgical Procedures, Operative [E04]
- Registration Number
- CTIS2024-512194-27-01
- Lead Sponsor
- Hospital Universitario Ramon Y Cajal
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 394
Age 18 years or older, Patients undergoing elective outpatient colonoscopy for any indication, Anticoagulant treatment with VKA (acenocoumarol or warfarin) or OACD (dabigatran, edoxaban, apixaban or rivaroxaban) prior to colonoscopy
Concomitant antiagregant treatment, Planned endoscopic dilatation, Severe psychiatric disorder, Removal of colorectal lesion by endoscopic submucosal dissection, Previous diagnosis of renal failure defined as creatinine >2 mg/dl or clearance < 30 ml/min, Planned procedure of high haemorrhagic risk in simultaneously performed gastroscopy, Prior trial enrolment. Patients may only be included on one occasion, Any clinical situation or concomitant treatment that in the investigator's judgement poses a significant bleeding risk, Age > 85 years old, Urgent colonoscopy, Labile INR (time in therapeutic range less than 60%) documented in the previous 3 months in patients receiving VKAs, Supra-therapeutic INR (> 3.5) at the time of the procedure in patients receiving VKA, Pregnancy, Decompensated liver cirrhosis, Inability, in the investigator's judgement, to understand the periprocedural anticoagulation regimen, Previously known coagulopathy or bleeding diathesis. Includes plateletopenia < 50,000/µL in the previous 12 months
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method