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临床试验/NCT04766606
NCT04766606已完成不适用

Management of Anticoagulant Therapy in Non-cardiac Surgical Patients in Relation to Their Postoperative Clinical Outcome.

University of Ioannina1 个研究点 分布在 1 个国家目标入组 614 人开始时间: 2018年5月8日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
614
试验地点
1
主要终点
Perioeprative antithrombotic management in elective non-cardiac elective surgery.

研究概览

简要总结

The perioperative treatment of patients receiving long-term anticoagulant therapy is challenging. This is attributed to the continuation of anticoagulants perioperatively, which is associated with an increased bleeding risk while their discontinuation increases the risk of thromboembolic or ischemic events.

Type of surgery and patient's comorbidities (i.e. haematological diseases, renal or hepatic insufficiency, and concomitant use of other anticoagulants) are significant factors associated with perioperative bleeding. Bleeding risk is stratifies according to the 2011 Canadian Cardiovascular Society Guidelines for the Management of Patients with Antiplatelet Disorder. Surgical thrombotic risk assessment is based on 2014 ESC / ESA Guidelines on non-cardiac surgery.

The purpose of this study is to investigate and record the management of anticoagulant therapy and long term outcome. The primary target is to record the anticoagulant management in non-cardiac elective surgery during one year in our Hospital. The study involves the investigation of the degree of compliance according to published guidelines. Immediate postoperative complications and major events are secondary goals. Data are assessed at 30, 90 days and one year follow up after surgery.

Understanding the need to discontinue or not antithrombotic agents and adapting treatment strategies according to type of surgery is the key to balance their safety and efficacy. Cardiologists, surgeons, and anaesthesiologists should be aware of the potential catastrophic risks of early discontinuation or continuation of antithrombotic therapy.

详细描述

It is estimated that more than 150,000 patients receive anticoagulant treatment in Greece. More than 10% of those will need to undergo surgery annually. Major side effects of all anticoagulants are bleeding or major thromboembolic events perioperatively.

The perioperative treatment of patients receiving long-term anticoagulant therapy is challenging. This is attributed to the continuation of anticoagulants perioperatively, which is associated with an increased bleeding risk while their discontinuation increases the risk of thromboembolic or ischemic events.

Type of surgery and patient's comorbidities (i.e. haematological diseases, renal or hepatic insufficiency, and concomitant use of other anticoagulants) are significant factors associated with perioperative bleeding. According to the 2011 Canadian Cardiovascular Society Guidelines for the Management of Patients with Antiplatelet Disorder, bleeding risk is stratified as following:

  • Very high risk: neurosurgery (intracranial or spinal surgery), cardiac surgery (coronary artery bypass grafting or valve replacement).
  • Medium risk: intrathoracic, intra-abdominal procedures, orthopaedic, vascular and other selective procedures (prostate or cervical biopsy).
  • High Risk: major vascular surgeries (abdominal aortic aneurysm, aortic bypass), major orthopaedic surgery on the lower extremity (total hip / knee), pneumonectomy, enterectomy, placement of permanent pacemaker or internal defibrillator and other selected procedures (kidney biopsy, pericardium puncture, resection of colon polyps).
  • Low risk: laparoscopic procedures (cholecystectomy, inguinal hernia repair), dental, dermatological, ophthalmic procedures, coronary angiography, gastroscopy /colonoscopy and other selected procedures (bone marrow or lymph node biopsy, thoracotomy, joint puncture).
  • Very low risk: low risk dental procedures (i.e. tooth extraction), skin biopsy or skin cancer excision, cataract surgery.

Surgical thrombotic risk assessment is based on 2014 ESC / ESA Guidelines on non-cardiac surgery. Low risk (<1%) surgeries include superficial surgery, breast procedures etc., medium risk (1-5%) splenectomy, cholecystectomy, etc., and high risk (>5%) are major aortic and other major blood vessel operations, open limb revascularization or amputation or embolectomy, gastric surgery, hepatectomy, etc.

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

入选标准

  • elective surgery
  • non-cardiac surgery
  • general, urological, orthopaedic, gynecological, ophthalmological, ENT, plastic surgery and neurosurgery

排除标准

  • age under 18 years old
  • emergency surgery
  • mental disorders
  • caesarean sections
  • surgeries lasting less more than 20 minutes
  • patients' refusal

结局指标

主要结局

Perioeprative antithrombotic management in elective non-cardiac elective surgery.

时间窗: Postoperatively (until 30 days after surgery).

Recording time of re-administration of antithrombotic therapy postoperatively.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

BOLOSI MARIA

Consultant Anaesthesiologist

University of Ioannina

研究点 (1)

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