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Completed

NCT Number: NCT03893357

Prevalence of Antiphospholipid Antibodies in the Hemodialysis Patients Population Within 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU Brugmann

Brussels, 1020, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Data extraction from medical files

Other

Retrospective data extraction from the medical files

Primary outcomes

  1. Prevalence of antiphospholipid antibodies

    Time frame: 19 years

    Prevalence of antiphospholipid antibodies

  2. Prevalence of arterial thrombosis

    Time frame: 19 years

    Prevalence of arterial thrombosis

  3. Prevalence of venous thrombosis

    Time frame: 19 years

    Prevalence of venous thrombosis

  4. Maturation delay of the arteriovenous fistula

    Time frame: 19 years

    Maturation delay of the arteriovenous fistula

  5. Percentage of thrombosis of the filter

    Time frame: 19 years

    Percentage of thrombosis of the filter

  6. Lifespan of the catheter

    Time frame: 19 years

    Lifespan of the catheter

  7. Lifespan of the fistula

    Time frame: 19 years

    Lifespan of the fistula

Secondary outcomes

  1. Existence of thrombosis risk factors

    Time frame: 19 years

    Existence of at least one of the following pro-thrombotic risk factors: smoking, active neoplasia, arterial hypertension.

  2. Anticoagulant treatment

    Time frame: 19 years

    Existence of an anticoagulant treatment

    Presence of an anticoagulant treatment by means of anti-vitamin K

  3. Antiplatelet treatment Antiplatelet treatment

    Time frame: 19 years

    Existence of an antiplatelet treatment

  4. Antihypertensive treatment

    Time frame: 19 years

    Existence of an antihypertensive treatment

  5. Statin treatment

    Time frame: 19 years

    Existence of a treatment by means of statins

  6. Ethiology of the nephropathy (known/unknown)

    Time frame: 19 years

    Known versus unknown ethiology

  7. Ethiology of the nephropathy (glomerular)

    Time frame: 19 years

    Glomerular versus non-glomerular ethiology

  8. Age at dialysis entry

    Time frame: 19 years

    Age at dialysis entry

  9. Vascular access

    Time frame: 19 years

    Catheter versus distal arteriovenous fistula versus proximal arteriovenous fistula

  10. Type of dialysis

    Time frame: 19 years

    Hemodiafiltration versus conventional hemodialysis

  11. Type of per-dialytic anticoagulation

    Time frame: 19 years

    With or without heparin

  12. Brand of dialysis membrane

    Time frame: 19 years

    Brand of dialysis membrane

  13. Urea change percentage

    Time frame: Last available result within 19 years

    Urea change percentage

  14. Activated partial thromboplastin time (aPTT)

    Time frame: Last available result within 19 years

    Coagulation assessment

  15. Hemoglobin count

    Time frame: Last available result within 19 years

    Hemoglobin count

  16. Platelets count

    Time frame: Last available result within 19 years

    Platelets count

Sponsors and collaborators

Lead sponsor

Brugmann University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Mar 28, 2019
Registry last updated
Jan 27, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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