Clinical trial NCT03893357: Prevalence of Antiphospholipid Antibodies in the Hemodialysis Patients Population Within the CHU Brugmann Hospital
Official title: Retrospective Study of the Prevalence of Antiphospholipid Antibodies in the Population of Hemodialysis Patients at the CHU Brugmann Hospital
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Antiphospholipid Syndrome
Lead sponsor: Brugmann University Hospital
Sponsor class: OTHER
First posted: 2019-03-28
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients undergoing dialysis within the CHU Brugmann Hospital.

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.


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

Primary outcomes:
measure: Prevalence of antiphospholipid antibodies
timeFrame: 19 years
measure: Prevalence of arterial thrombosis
timeFrame: 19 years
measure: Prevalence of venous thrombosis
timeFrame: 19 years
measure: Maturation delay of the arteriovenous fistula
timeFrame: 19 years
measure: Percentage of thrombosis of the filter
timeFrame: 19 years
measure: Lifespan of the catheter
timeFrame: 19 years
measure: Lifespan of the fistula
timeFrame: 19 years
Secondary outcomes:
measure: Existence of thrombosis risk factors
timeFrame: 19 years
measure: Anticoagulant treatment
timeFrame: 19 years
measure: Antiplatelet treatment Antiplatelet treatment
timeFrame: 19 years
measure: Antihypertensive treatment
timeFrame: 19 years
measure: Statin treatment
timeFrame: 19 years
measure: Ethiology of the nephropathy (known/unknown)
timeFrame: 19 years
measure: Ethiology of the nephropathy (glomerular)
timeFrame: 19 years
measure: Age at dialysis entry
timeFrame: 19 years
measure: Vascular access
timeFrame: 19 years
measure: Type of dialysis
timeFrame: 19 years
measure: Type of per-dialytic anticoagulation
timeFrame: 19 years
measure: Brand of dialysis membrane
timeFrame: 19 years
measure: Urea change percentage
timeFrame: Last available result within 19 years
measure: Activated partial thromboplastin time (aPTT)
timeFrame: Last available result within 19 years
measure: Hemoglobin count
timeFrame: Last available result within 19 years
measure: Platelets count
timeFrame: Last available result within 19 years
Other outcomes:
Locations:
city: Brussel
country: Belgium
facility: CHU Brugmann
Study officials:
affiliation: CHU Brugmann
name: Camara Fatim, MD
role: PRINCIPAL_INVESTIGATOR
References: