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临床试验/NCT03893357
NCT03893357已完成不适用

Retrospective Study of the Prevalence of Antiphospholipid Antibodies in the Population of Hemodialysis Patients at the CHU Brugmann Hospital

Brugmann University Hospital1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2019年3月1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
100
试验地点
1
主要终点
Maturation delay of the arteriovenous fistula

研究概览

简要总结

In patients with a chronic renal disease at the terminal stage, extrarenal epuration is essential for the control of clinico-biological complications. Two extrarenal epuration techniques are currently available: peritoneal dialysis (using the peritoneal membrane of the patient) and hemodialysis, requiring the use of an external biocompatible membrane known as 'dialysis filter'. This technique requires a vascular access (arteriovenous fistula or dialysis catheter). The thrombosis of vascular accesses represents a major cause of morbidity and mortality in hemodialysis patients. Thrombosis are more frequent when using synthetic prosthetic arteriovenous fistula instead of native arteriovenous fistula.

Antiphospholipid Syndrome (APLS) is a rare autoimmune disease characterized by arterial thrombosis, venous thrombosis and obstetrical complications such as as defined by the Sidney's criteria.

In the general population, the presence of antiphospholipid antibodies is associated with an increased risk of thromboembolic events. In the nephrological population, this prevalence is higher in hemodialysis patients compared to patients on peritoneal dialysis or non-dialyzed patients. Up to 37% of hemodialysis patients are positive for antiphospholipid antibodies and this biology is associated with thrombotic events and vascular access thromboses. However, some studies do not report this association and there is currently no consensus in terms of the therapeutic management of these patients.

Some factors influencing the positivity for antiphospholipid antibodies have been reported: smoking, age, the presence of a non-glomerular nephropathy, hypoalbuminaemia, the use of a central venous catheter for dialysis or the use of a non-biocompatible dialysis membrane.

Taking into account the conflicting data from the literature, it seems important to study the respective role(s) of 3 types of antiphospholipid antibodies in the occurrence of thrombo- embolic events in patients undergoing dialysis within the CHU Brugmann Hospital.

研究设计

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

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

  • All patients undergoing dialysis within the CHU Brugmann Hospital

排除标准

  • Mutation of factor V
  • Mutation G20210A of the prothrombin gene
  • Protein C deficiency
  • Protein S deficiency
  • Antithrombin III deficiency

结局指标

主要结局

Maturation delay of the arteriovenous fistula

时间窗: 19 years

Maturation delay of the arteriovenous fistula

Percentage of thrombosis of the filter

时间窗: 19 years

Percentage of thrombosis of the filter

Lifespan of the fistula

时间窗: 19 years

Lifespan of the fistula

Prevalence of antiphospholipid antibodies

时间窗: 19 years

Prevalence of antiphospholipid antibodies

Prevalence of venous thrombosis

时间窗: 19 years

Prevalence of venous thrombosis

Lifespan of the catheter

时间窗: 19 years

Lifespan of the catheter

Prevalence of arterial thrombosis

时间窗: 19 years

Prevalence of arterial thrombosis

次要结局

  • Brand of dialysis membrane(19 years)
  • Hemoglobin count(Last available result within 19 years)
  • Vascular access(19 years)
  • Urea change percentage(Last available result within 19 years)
  • Antihypertensive treatment(19 years)
  • Age at dialysis entry(19 years)
  • Anticoagulant treatment(19 years)
  • Antiplatelet treatment Antiplatelet treatment(19 years)
  • Type of dialysis(19 years)
  • Statin treatment(19 years)
  • Ethiology of the nephropathy (known/unknown)(19 years)
  • Type of per-dialytic anticoagulation(19 years)
  • Platelets count(Last available result within 19 years)
  • Existence of thrombosis risk factors(19 years)
  • Ethiology of the nephropathy (glomerular)(19 years)
  • Activated partial thromboplastin time (aPTT)(Last available result within 19 years)

研究者

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

Agnieszka Pozdzik

Head of clinic

Brugmann University Hospital

研究点 (1)

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