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临床试验/NCT07019077
NCT07019077招募中不适用

Incidence of Late Haemorrhage After Invasive Gastroenterological Endoscopic Manoeuvre in Patients Treated With Anticoagulants Compared to Non-anticoagulated Patients

Centro Cardiologico Monzino1 个研究点 分布在 1 个国家目标入组 4,719 人开始时间: 2025年5月19日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
4,719
试验地点
1
主要终点
Incidence of late bleeding

研究概览

简要总结

Patients on oral anticoagulant therapy with vitamin K antagonists (AVKs; warfarin and acenocoumarol) and direct oral anticoagulants (DOACs; apixaban, dabigatran, edoxaban and rivaroxaban), are advised to consider discontinuing treatment in anticipation of invasive manoeuvres. Guidelines and expert consensus recommend, in clinical conditions with a high risk of bleeding, to suspend oral anticoagulant treatment with DOACs 2 or 3 days before the procedure, depending on the glomerular filtrate, to suspend warfarin from day -5 and acenocoumarol from day -4, and to introduce heparins from day -3 after discontinuation of AVKs (so-called 'bridging therapy') for manoeuvres with a high risk of bleeding. In manoeuvres with a low bleeding risk it is possible not to suspend the anticoagulant or to reduce its intensity. Obviously, the patient's intrinsic haemorrhagic and thrombotic risk (antiplatelet intake, renal insufficiency, hepatopathy, age, mechanical valve prosthesis, oncological condition, etc.) must also be taken into account in the overall assessment of pre-procedural preparation.

Gastroenterological endoscopic manoeuvres are generally considered to be at low haemorrhagic risk even if biopsy is planned, but are at high haemorrhagic risk if polypectomy or mucosectomy is planned. The most complex problem arises at the time of re-introduction of anticoagulant post-procedure. In fact, studies evaluating this specific aspect are very few and heterogeneous and mostly retrospective. The variables that are associated with an increased risk of bleeding are: the number and site of polypectomies, the diameter of the polyps, and local haemostasis techniques. Late haemorrhages (>24 hours) are of concern because the patient is generally at home and because, by the time the eschar falls out (varying between 4 and 10 days post-procedure), they have already resumed anticoagulation. However, there are no prospective studies of sufficient number to clarify whether the reintroduction of anticoagulation modifies the haemorrhagic risk, when is the time of greatest risk after the procedure, and which variables associated with the patient and the procedure most modify the haemorrhagic risk.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Age >= 18 years
  • •Expected endoscopic manoeuvre among those listed below
  • •EGDS ± biopsy/polypectomy
  • •Colonoscopy ± biopsy/polypectomy
  • •Echoguided endoscopy ± biopsy/polypectomy
  • •Double-balloon enteroscopy
  • •ERCP (endoscopic retrograde cholangio-pancreatography) ± sphincterotomy

排除标准

  • •Age < 18 years
  • •Known active neoplasms of the gastroenteric tract
  • •Gastrointestinal procedures performed as an emergency
  • •Patients with an intrinsic haemorrhagic diathesis (e.g. known plateletopenia < 50,000/mmc)
  • •Patients on antiplatelet treatment with clopidogrel or other thienopyridines

结局指标

主要结局

Incidence of late bleeding

时间窗: 30 days after the manoeuvre.

The primary objective is to assess the incidence of late (\>24 hours) bleeding from the gastro-enteric tract in anticoagulated patients after low and high risk endoscopic manoeuvres and to compare it with that observed in non-anticoagulated patients in the first 30 days after the manoeuvre.

次要结局

  • Incidence of early bleeding(First 24 hours)

研究者

发起方
Centro Cardiologico Monzino
申办方类型
Other
责任方
Principal Investigator
主要研究者

Barbara Scimeca

Principal Investigator - Medical Doctor

Centro Cardiologico Monzino

研究点 (1)

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