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

Antiphospholipid Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03893357
• Other study ID #: CHUB-Fatim
• Status: Completed
• Start date: March 1, 2019
• Est. completion date: July 25, 2019

Study information

• Verified date: January 2020
• Source: Brugmann University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: July 25, 2019
• Est. primary completion date: July 25, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Antiphospholipid Syndrome

Intervention

Other:
• Data extraction from medical files
Retrospective data extraction from the medical files

Locations

Country	Name	City	State
Belgium	CHU Brugmann	Brussel

Sponsors (1)

Lead Sponsor	Collaborator
Brugmann University Hospital

Country where clinical trial is conducted

Belgium, 

Outcome

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