BridgeMD
Short-term interruption versus continuous anticoagulation in colorectal polypectomy. A randomized multicenter investigator-initiated non-inferiority clinical trial: the POLYPHEM trial.
EU CTIS ID: 2024-512194-27-01
What this study is testing
To evaluate the safety of maintaining anticoagulationtratment during polypectomy in colorrectal lesions.
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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
You likely can't join if
- 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
See the full eligibility criteria
- 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
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.