Short-term interruption versus continuous anticoagulation in colorectal polypectomy. A randomized multicenter investigator-initiated non-inferiority clinical trial: the POLYPHEM trial.
ESTADO CLÍNICO
Reclutando
FASE/S DEL ENSAYO
Fase IV
PATOLOGÍA
Trombosis y Anticoagulantes
CENTRO INVESTIGADOR
H.U. Ramón y Cajal
INVESTIGADOR PRINCIPAL
Enrique Rodríguez de Santiago
FECHA DE APERTURA
Junio, 2024
FECHA DE CIERRE
,
CRITERIOS DE INCLUSIÓN
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
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
CRITERIOS DE EXCLUSIÓN
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
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
DESCRIPCIÓN
To evaluate the safety of maintaining anticoagulationtratment during polypectomy in colorrectal lesions.
PALABRAS CLAVE
anticoagulation
