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

NCT03893357 | Completed

• 1 other identifier: CHUB-Fatim
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (7)

• 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 Outcomes (16)

• Existence of thrombosis risk factors

  19 years

• Anticoagulant treatment

  19 years

• Antiplatelet treatment Antiplatelet treatment

  19 years

• Antihypertensive treatment

  19 years

• Statin treatment

  19 years

Study Arms (2)

Positive for antiphospholipid antibodies

Patients tested positive for antiphospholipid antibodies

Other: Data extraction from medical files

Negative for antiphospholipid antibodies

Patients tested negative for antiphospholipid antibodies

Other: Data extraction from medical files

Interventions

Data extraction from medical files OTHER

Retrospective data extraction from the medical files

Negative for antiphospholipid antibodies; Positive for antiphospholipid antibodies

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients undergoing dialysis within the CHU Brugmann Hospital.

You may qualify if:

• \- All patients undergoing dialysis within the CHU Brugmann Hospital

You may not qualify if:

• Mutation of factor V
• Mutation G20210A of the prothrombin gene
• Protein C deficiency
• Protein S deficiency
• Antithrombin III deficiency

Sponsors & Collaborators

• Brugmann University Hospital: lead

Study Sites (1)

CHU Brugmann

Brussels, 1020, Belgium

Location

MeSH Terms

Conditions

Antiphospholipid Syndrome

Condition Hierarchy (Ancestors)

Autoimmune Diseases; Immune System Diseases

Study Officials

• Camara Fatim, MD

  CHU Brugmann

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of clinic

Study Record Dates

• First Submitted: March 26, 2019
• First Posted: March 28, 2019
• Study Start: March 1, 2019
• Primary Completion: July 25, 2019
• Study Completion: July 25, 2019
• Last Updated: January 27, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)