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

NCT ID: NCT03893357

Last Updated: 2020-01-27

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-03-01
• Study Completion Date: 2019-07-25

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.

Conditions

Antiphospholipid Syndrome

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Positive for antiphospholipid antibodies

Patients tested positive for antiphospholipid antibodies

Data extraction from medical files

Intervention Type: OTHER

Retrospective data extraction from the medical files

Negative for antiphospholipid antibodies

Patients tested negative for antiphospholipid antibodies

Data extraction from medical files

Intervention Type: OTHER

Retrospective data extraction from the medical files

Interventions

Data extraction from medical files

Retrospective data extraction from the medical files

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Brugmann University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Agnieszka Pozdzik

Head of clinic

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Camara Fatim, MD

Role: PRINCIPAL_INVESTIGATOR

CHU Brugmann

Locations

CHU Brugmann

Brussels, , Belgium

Countries

Belgium

Other Identifiers

CHUB-Fatim

Identifier Type: -

Identifier Source: org_study_id