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Clinical Trials/NCT03893357
NCT03893357
Completed
Not Applicable

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

Brugmann University Hospital1 site in 1 country100 target enrollmentMarch 1, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Antiphospholipid Syndrome
Sponsor
Brugmann University Hospital
Enrollment
100
Locations
1
Primary Endpoint
Maturation delay of the arteriovenous fistula
Status
Completed
Last Updated
6 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
March 1, 2019
End Date
July 25, 2019
Last Updated
6 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Agnieszka Pozdzik

Head of clinic

Brugmann University Hospital

Eligibility Criteria

Inclusion Criteria

  • All patients undergoing dialysis within the CHU Brugmann Hospital

Exclusion Criteria

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

Outcomes

Primary Outcomes

Maturation delay of the arteriovenous fistula

Time Frame: 19 years

Maturation delay of the arteriovenous fistula

Percentage of thrombosis of the filter

Time Frame: 19 years

Percentage of thrombosis of the filter

Lifespan of the fistula

Time Frame: 19 years

Lifespan of the fistula

Prevalence of antiphospholipid antibodies

Time Frame: 19 years

Prevalence of antiphospholipid antibodies

Prevalence of venous thrombosis

Time Frame: 19 years

Prevalence of venous thrombosis

Lifespan of the catheter

Time Frame: 19 years

Lifespan of the catheter

Prevalence of arterial thrombosis

Time Frame: 19 years

Prevalence of arterial thrombosis

Secondary Outcomes

  • 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)

Study Sites (1)

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