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Trial record 100 of 1734 for:    Recruiting, Not yet recruiting, Available Studies | Autoimmunity

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

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ClinicalTrials.gov Identifier: NCT03893357
Recruitment Status : Recruiting
First Posted : March 28, 2019
Last Update Posted : May 13, 2019
Sponsor:
Information provided by (Responsible Party):
Agnieszka Pozdzik, Brugmann University Hospital

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.


Condition or disease Intervention/treatment
Antiphospholipid Syndrome Other: Data extraction from medical files

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Study Type : Observational
Estimated Enrollment : 153 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Retrospective Study of the Prevalence of Antiphospholipid Antibodies in the Population of Hemodialysis Patients at the CHU Brugmann Hospital
Actual Study Start Date : March 1, 2019
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019


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




Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All patients undergoing dialysis within the CHU Brugmann Hospital.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03893357


Contacts
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Contact: Camara Fatim, MD +32 487 225 056 Fatim.camara@ulb.ac.be

Locations
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Belgium
CHU Brugmann Recruiting
Brussel, Belgium, 1020
Contact: Camara Fatim, MD         
Principal Investigator: Camara Fatim, MD         
Principal Investigator: Maxime Thagavi, MD         
Sponsors and Collaborators
Brugmann University Hospital
Investigators
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Principal Investigator: Camara Fatim, MD CHU Brugmann

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Responsible Party: Agnieszka Pozdzik, Head of clinic, Brugmann University Hospital
ClinicalTrials.gov Identifier: NCT03893357     History of Changes
Other Study ID Numbers: CHUB-Fatim
First Posted: March 28, 2019    Key Record Dates
Last Update Posted: May 13, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Antiphospholipid Syndrome
Autoimmune Diseases
Immune System Diseases
Antibodies
Immunoglobulins
Antibodies, Antiphospholipid
Immunologic Factors
Physiological Effects of Drugs