CTIS2024-512194-27-01进行中（未招募）1 期
Short-term interruption versus continuous anticoagulation in colorectal polypectomy. A randomized multicenter investigator-initiated non-inferiority clinical trial: the POLYPHEM trial.
Hospital Universitario Ramon Y Cajal0 个研究点目标入组 394 人开始时间: 2024年4月12日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 394
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 65+（—）
- 性别
- All
入选标准
- •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
排除标准
- •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
研究者
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