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Prevalence of Antiphospholipid Antibodies in the Hemodialysis Patients Population Within the CHU Brugmann Hospital

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03893357
Enrollment
100
Registered
2019-03-28
Start date
2019-03-01
Completion date
2019-07-25
Last updated
2020-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Antiphospholipid Syndrome

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.

Interventions

Retrospective data extraction from the medical files

Sponsors

Brugmann University Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Prevalence of antiphospholipid antibodies19 yearsPrevalence of antiphospholipid antibodies
Prevalence of arterial thrombosis19 yearsPrevalence of arterial thrombosis
Prevalence of venous thrombosis19 yearsPrevalence of venous thrombosis
Maturation delay of the arteriovenous fistula19 yearsMaturation delay of the arteriovenous fistula
Percentage of thrombosis of the filter19 yearsPercentage of thrombosis of the filter
Lifespan of the catheter19 yearsLifespan of the catheter
Lifespan of the fistula19 yearsLifespan of the fistula

Secondary

MeasureTime frameDescription
Ethiology of the nephropathy (known/unknown)19 yearsKnown versus unknown ethiology
Ethiology of the nephropathy (glomerular)19 yearsGlomerular versus non-glomerular ethiology
Age at dialysis entry19 yearsAge at dialysis entry
Vascular access19 yearsCatheter versus distal arteriovenous fistula versus proximal arteriovenous fistula
Hemoglobin countLast available result within 19 yearsHemoglobin count
Type of per-dialytic anticoagulation19 yearsWith or without heparin
Brand of dialysis membrane19 yearsBrand of dialysis membrane
Urea change percentageLast available result within 19 yearsUrea change percentage
Activated partial thromboplastin time (aPTT)Last available result within 19 yearsCoagulation assessment
Type of dialysis19 yearsHemodiafiltration versus conventional hemodialysis
Platelets countLast available result within 19 yearsPlatelets count
Existence of thrombosis risk factors19 yearsExistence of at least one of the following pro-thrombotic risk factors: smoking, active neoplasia, arterial hypertension.
Anticoagulant treatment19 yearsExistence of an anticoagulant treatment Presence of an anticoagulant treatment by means of anti-vitamin K
Antiplatelet treatment Antiplatelet treatment19 yearsExistence of an antiplatelet treatment
Antihypertensive treatment19 yearsExistence of an antihypertensive treatment
Statin treatment19 yearsExistence of a treatment by means of statins

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026