Antiphospholipid SyndromeNCT03893357
Prevalence of Antiphospholipid Antibodies in the Hemodialysis Patients Population Within the CHU Brugmann Hospital
An observational study of Antiphospholipid Syndrome, run by Brugmann University Hospital at 1 site in Belgium.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Antiphospholipid Syndrome
- What is being tested?
- Data extraction from medical files
- How many people
- 100 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Mar 2019to 25 Jul 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients undergoing dialysis within the CHU Brugmann Hospital.
Who may be able to join
- All patients undergoing dialysis within the CHU Brugmann Hospital
Who cannot join
- Mutation of factor V
- Mutation G20210A of the prothrombin gene
- Protein C deficiency
- Protein S deficiency
- Antithrombin III deficiency
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Retrospective Study of the Prevalence of Antiphospholipid Antibodies in the Population of Hemodialysis Patients at 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.
Read more
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
- Being tested
- Data extraction from medical files
- Medical subject headings
- Antiphospholipid Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Data extraction from medical filesOther
Retrospective data extraction from the medical files
| Study group | Role | What they receive |
|---|---|---|
| Positive for antiphospholipid antibodies | Patients tested positive for antiphospholipid antibodies Receives: Other: Data extraction from medical files | |
| Negative for antiphospholipid antibodies | Patients tested negative for antiphospholipid antibodies Receives: Other: Data extraction from medical files |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of antiphospholipid antibodies
Prevalence of antiphospholipid antibodies
Measured: 19 years
Prevalence of arterial thrombosis
Prevalence of arterial thrombosis
Measured: 19 years
Prevalence of venous thrombosis
Prevalence of venous thrombosis
Measured: 19 years
Maturation delay of the arteriovenous fistula
Maturation delay of the arteriovenous fistula
Measured: 19 years
Percentage of thrombosis of the filter
Percentage of thrombosis of the filter
Measured: 19 years
Lifespan of the catheter
Lifespan of the catheter
Measured: 19 years
Lifespan of the fistula
Lifespan of the fistula
Measured: 19 years
Secondary outcomes (16)
Existence of thrombosis risk factors
Existence of at least one of the following pro-thrombotic risk factors: smoking, active neoplasia, arterial hypertension.
Measured: 19 years
Anticoagulant treatment
Existence of an anticoagulant treatment
Presence of an anticoagulant treatment by means of anti-vitamin K
Measured: 19 years
Antiplatelet treatment Antiplatelet treatment
Existence of an antiplatelet treatment
Measured: 19 years
Antihypertensive treatment
Existence of an antihypertensive treatment
Measured: 19 years
Statin treatment
Existence of a treatment by means of statins
Measured: 19 years
Ethiology of the nephropathy (known/unknown)
Known versus unknown ethiology
Measured: 19 years
Ethiology of the nephropathy (glomerular)
Glomerular versus non-glomerular ethiology
Measured: 19 years
Age at dialysis entry
Age at dialysis entry
Measured: 19 years
Vascular access
Catheter versus distal arteriovenous fistula versus proximal arteriovenous fistula
Measured: 19 years
Type of dialysis
Hemodiafiltration versus conventional hemodialysis
Measured: 19 years
Type of per-dialytic anticoagulation
With or without heparin
Measured: 19 years
Brand of dialysis membrane
Brand of dialysis membrane
Measured: 19 years
Urea change percentage
Urea change percentage
Measured: Last available result within 19 years
Activated partial thromboplastin time (aPTT)
Coagulation assessment
Measured: Last available result within 19 years
Hemoglobin count
Hemoglobin count
Measured: Last available result within 19 years
Platelets count
Platelets count
Measured: Last available result within 19 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2019
- Study start1 Mar 2019
- Primary completion25 Jul 2019
- Study completion25 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Antiphospholipid SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brugmann University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Agnieszka Pozdzik, Brugmann University Hospital
- Investigators
- Camara Fatim, MD, Principal investigator, CHU Brugmann
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03893357
- Sponsor's protocol ID
- CHUB-Fatim
- Status last verified
- Jan 2020
- First submitted
- 26 Mar 2019
- Last updated
- 27 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Study of the Prevalence of Antiphospholipid Antibodies in the Population of Hemodialysis Patients at the CHU Brugmann Hospital
- ClinicalTrials.gov ID
- NCT03893357
- Acronym / sponsor ID
- CHUB-Fatim
- Conditions
- Antiphospholipid Syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Brugmann University HospitalUniversity, hospital or other
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 25 Jul 2019 (actual)
- Study completion
- 25 Jul 2019 (actual)
- First posted
- 28 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Positive for antiphospholipid antibodies | – | Other: Data extraction from medical filesPatients tested positive for antiphospholipid antibodies |
| Negative for antiphospholipid antibodies | – | Other: Data extraction from medical filesPatients tested negative for antiphospholipid antibodies |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients undergoing dialysis within the CHU Brugmann Hospital.
Key inclusion criteria (1 listed)
- All patients undergoing dialysis within the CHU Brugmann Hospital
Key exclusion criteria (5 listed)
- Mutation of factor V
- Mutation G20210A of the prothrombin gene
- Protein C deficiency
- Protein S deficiency
- Antithrombin III deficiency
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Data extraction from medical filesRetrospective data extraction from the medical files | Other | Negative for antiphospholipid antibodies, Positive for antiphospholipid antibodies |
Primary outcome
Prevalence of antiphospholipid antibodies
Time frame: 19 years
Prevalence of antiphospholipid antibodies
Prevalence of arterial thrombosis
Time frame: 19 years
Prevalence of arterial thrombosis
Prevalence of venous thrombosis
Time frame: 19 years
Prevalence of venous thrombosis
Maturation delay of the arteriovenous fistula
Time frame: 19 years
Maturation delay of the arteriovenous fistula
Percentage of thrombosis of the filter
Time frame: 19 years
Percentage of thrombosis of the filter
Lifespan of the catheter
Time frame: 19 years
Lifespan of the catheter
Lifespan of the fistula
Time frame: 19 years
Lifespan of the fistula
16 secondary outcomes
Existence of thrombosis risk factors
Time frame: 19 years
Anticoagulant treatment
Time frame: 19 years
Antiplatelet treatment Antiplatelet treatment
Time frame: 19 years
Antihypertensive treatment
Time frame: 19 years
Statin treatment
Time frame: 19 years
Ethiology of the nephropathy (known/unknown)
Time frame: 19 years
Ethiology of the nephropathy (glomerular)
Time frame: 19 years
Age at dialysis entry
Time frame: 19 years
Vascular access
Time frame: 19 years
Type of dialysis
Time frame: 19 years
Type of per-dialytic anticoagulation
Time frame: 19 years
Brand of dialysis membrane
Time frame: 19 years
Urea change percentage
Time frame: Last available result within 19 years
Activated partial thromboplastin time (aPTT)
Time frame: Last available result within 19 years
Hemoglobin count
Time frame: Last available result within 19 years
Platelets count
Time frame: Last available result within 19 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Camara Fatim, MD principal investigator
CHU Brugmann
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Antiphospholipid Syndrome, run by Brugmann University Hospital at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of antiphospholipid antibodies (time frame: 19 years). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2020.