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

Completed

• Conditions: Antiphospholipid Syndrome

• Registration Number: NCT03893357
• Lead Sponsor: Brugmann University 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-03-01
• Study First Submitted: 2019-03-26
• Study First Submitted QC: 2019-03-27
• Study First Posted: 2019-03-28
• Primary Completion: 2019-07-25
• Study Completion: 2019-07-25
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-24
• Last Update Posted: 2020-01-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Lifespan of the fistula	19 years	Lifespan of the fistula
Maturation delay of the arteriovenous fistula	19 years	Maturation delay of the arteriovenous fistula
Percentage of thrombosis of the filter	19 years	Percentage of thrombosis of the filter
Prevalence of antiphospholipid antibodies	19 years	Prevalence of antiphospholipid antibodies
Prevalence of venous thrombosis	19 years	Prevalence of venous thrombosis
Lifespan of the catheter	19 years	Lifespan of the catheter
Prevalence of arterial thrombosis	19 years	Prevalence of arterial thrombosis

Secondary Outcome Measures

Name	Time	Method
Antihypertensive treatment	19 years	Existence of an antihypertensive treatment
Vascular access	19 years	Catheter versus distal arteriovenous fistula versus proximal arteriovenous fistula
Urea change percentage	Last available result within 19 years	Urea change percentage
Age at dialysis entry	19 years	Age at dialysis entry
Anticoagulant treatment	19 years	Existence of an anticoagulant treatment; Presence of an anticoagulant treatment by means of anti-vitamin K
Antiplatelet treatment Antiplatelet treatment	19 years	Existence of an antiplatelet treatment
Type of dialysis	19 years	Hemodiafiltration versus conventional hemodialysis
Statin treatment	19 years	Existence of a treatment by means of statins
Ethiology of the nephropathy (known/unknown)	19 years	Known versus unknown ethiology
Type of per-dialytic anticoagulation	19 years	With or without heparin
Platelets count	Last available result within 19 years	Platelets count
Existence of thrombosis risk factors	19 years	Existence of at least one of the following pro-thrombotic risk factors: smoking, active neoplasia, arterial hypertension.
Ethiology of the nephropathy (glomerular)	19 years	Glomerular versus non-glomerular ethiology
Activated partial thromboplastin time (aPTT)	Last available result within 19 years	Coagulation assessment
Brand of dialysis membrane	19 years	Brand of dialysis membrane
Hemoglobin count	Last available result within 19 years	Hemoglobin count

Trial Locations

Locations (1)

CHU Brugmann; 🇧🇪 Brussel, Belgium