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

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.

Study Overview

• Status: Completed
• Conditions: Antiphospholipid Syndrome
• Intervention / Treatment: Other: Data extraction from medical files

• Study Type: Observational
• Enrollment (Actual): 100

Contacts and Locations

Study Locations

• Belgium
  • Brussel, Belgium, 1020
    • CHU Brugmann

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All patients undergoing dialysis within the CHU Brugmann Hospital.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Positive for antiphospholipid antibodies; Patients tested positive for antiphospholipid antibodies	Other: Data extraction from medical files; Retrospective data extraction from the medical files
Negative for antiphospholipid antibodies; Patients tested negative for antiphospholipid antibodies	Other: Data extraction from medical files; Retrospective data extraction from the medical files

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prevalence of antiphospholipid antibodies	Prevalence of antiphospholipid antibodies	19 years
Prevalence of arterial thrombosis	Prevalence of arterial thrombosis	19 years
Prevalence of venous thrombosis	Prevalence of venous thrombosis	19 years
Maturation delay of the arteriovenous fistula	Maturation delay of the arteriovenous fistula	19 years
Percentage of thrombosis of the filter	Percentage of thrombosis of the filter	19 years
Lifespan of the catheter	Lifespan of the catheter	19 years
Lifespan of the fistula	Lifespan of the fistula	19 years

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Brugmann University Hospital
• Investigators: Principal Investigator: Camara Fatim, MD, CHU Brugmann

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2019
• Primary Completion (Actual): July 25, 2019
• Study Completion (Actual): July 25, 2019

Study Registration Dates

• First Submitted: March 26, 2019
• First Submitted That Met QC Criteria: March 27, 2019
• First Posted (Actual): March 28, 2019

Study Record Updates

• Last Update Posted (Actual): January 27, 2020
• Last Update Submitted That Met QC Criteria: January 24, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Antiphospholipid Syndrome
• Other Study ID Numbers: CHUB-Fatim

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No