HemophiliaERHEANCT03157154
Bleeding Risk Evaluation in Haemophilia Patients Under Antiplatelet Therapies
An observational study of Hemophilia, run by Nantes University Hospital at 6 sites in France.
Trial summary
Life expectancy of haemophilia patients (specially severe) has dramatically increase in the last decades, which lead to the apparition of aging diseases such as cardiovascular disease, with the potential bleeding risk of antiplatelet therapies and anticoagulants. Read more about this study
- Who is it for?
- Ages 50 years and older, men only
- Conditions the study is for
- Hemophilia
- What is being tested?
- Non interventional study
- How many people
- 259 participants
- Where
- 6 sitesFrance
- Study dates
- 27 Jun 2017to 30 Jul 2017
- 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 50 years and older
- Men only
- Adult, Older adult
Study population: Haemophilia patients (man, all severity) Age above 50 years, followed during the last 5 years in one of the study centre
Who may be able to join
- Male
- Age above 50 years
- Hemophilia A or B carriers
- Followed within the 5 last years in one of the research center
Who cannot join
- Jurisdictional prevention procedures
- Other medical condition that might interfere with the bleeding risk (Willebrand's disease, Other coagulation factor deficiencies, haematological malignancies, …)
- Other drugs that might interfere with the bleeding risk (Serotonin reuptake inhibitors)
- Patient refusal
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
France6 sites
Angers University Hospital
Angers, 49933
Brest University Hospital
Brest, 29609
Le Mans Hospital
La Mans, 72037
Lyon University Hospital
Lyon, 69000
Rennes University Hospital
Rennes, 35033
Tours University Hospital
Tours, 37170
About this study
Life expectancy of haemophilia patients (specially severe) has dramatically increase in the last decades, which lead to the apparition of aging diseases such as cardiovascular disease, with the potential bleeding risk of antiplatelet therapies and anticoagulants.
The primary endpoint of the study is to evaluate this bleeding risk in haemophilia patients (all severity) with such treatment in comparison to non treated patients, according to the number of bleeding events in the last year reported by the haemophilia patients under study treatment (antiplatelet and anticoagulant) in comparison to haemophilia patients free of such treatment. The main hypothesis is that antiplatelet and anticoagulant therapy can be safely used in minor haemophilia patients but might lead to increase bleeding risk in other haemophilia patients.
Read more
Secondary endpoint consist in:
- Evaluate the impact of know cardio-vascular risk in haemophilia patients (Odd ratios=OR)
- Evaluate the number of sever bleeding event in patient under study treatments compared to the control group
- Evaluate the overall consumption of factor VIII or IX supply in patients under study treatments compared to control group
- Estimate the stenosis relapse risk in haemophilia patients with arterial STENT
- Estimate the embolic risk of haemophilia patients with atrial fibrillation
Population description:
Haemophilia patients (man, all severity)
Age above 50 years, followed during the last 5 years in one of the study centre
- Conditions
- Hemophilia
- Being tested
- Non interventional study
- Keywords
- Haemophilia, Atherosclerosis, Atrial fibrillation, Antiplatelets, Anticoagulant
- Medical subject headings
- Hemophilia A, Atherosclerosis, Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non interventional studyOther
A query form to all concerned patients by each investigating centre will be send
| Study group | Role | What they receive |
|---|---|---|
| First group | Haemophilia patients with history of either cardiovascular disease or atrial fibrillation undergoing an antiplatelet or anticoagulant prophylaxis Receives: Other: Non interventional study | |
| Control group | Haemophilia patient without such history or treatment matched on age and disease status (haemophilia A or B and the severity of the disease : severe, mild, minor). Receives: Other: Non interventional study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of bleeding occurrences
Measured: last 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2017
- Study start27 Jun 2017
- Primary completion30 Jul 2017
- Study completion30 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HemophiliaStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 259 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marc Trossaërt, Dr, Principal investigator, Nantes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03157154
- Sponsor's protocol ID
- RC17_0150
- Acronym
- ERHEA
- Status last verified
- Jan 2020
- First submitted
- 16 May 2017
- Last updated
- 23 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Desjonqueres A, Guillet B, Beurrier P, Pan-Petesch B, Ardillon L, Pineau-Vincent F, Sigaud M, Fouassier M, Ternisien C, Gillet B, Bene MC, Horvais V, Lienhart A, Trossaert M. Bleeding risk for patients with haemophilia under antithrombotic therapy. Results of the French multicentric study ERHEA. Br J Haematol. 2019 May;185(4):764-767. doi: 10.1111/bjh.15606. Epub 2018 Oct 18. No abstract available.
PubMed 30338508
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bleeding Risk Evaluation in Haemophilia Patients Under Antiplatelet Therapies
- ClinicalTrials.gov ID
- NCT03157154
- Acronym / sponsor ID
- ERHEA / RC17_0150
- Conditions
- Hemophilia
- Keywords
- Haemophilia, Atherosclerosis, Atrial fibrillation, Antiplatelets, Anticoagulant
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 259 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- 27 Jun 2017 (actual)
- Primary completion
- 30 Jul 2017 (actual)
- Study completion
- 30 Jul 2017 (actual)
- First posted
- 17 May 2017 (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.
Life expectancy of haemophilia patients (specially severe) has dramatically increase in the last decades, which lead to the apparition of aging diseases such as cardiovascular disease, with the potential bleeding risk of antiplatelet therapies and anticoagulants.
The primary endpoint of the study is to evaluate this bleeding risk in haemophilia patients (all severity) with such treatment in comparison to non treated patients, according to the number of bleeding events in the last year reported by the haemophilia patients under study treatment (antiplatelet and anticoagulant) in comparison to haemophilia patients free of such treatment. The main hypothesis is that antiplatelet and anticoagulant therapy can be safely used in minor haemophilia patients but might lead to increase bleeding risk in other haemophilia patients.
Secondary endpoint consist in:
- Evaluate the impact of know cardio-vascular risk in haemophilia patients (Odd ratios=OR)
- Evaluate the number of sever bleeding event in patient under study treatments compared to the control group
- Evaluate the overall consumption of factor VIII or IX supply in patients under study treatments compared to control group
- Estimate the stenosis relapse risk in haemophilia patients with arterial STENT
- Estimate the embolic risk of haemophilia patients with atrial fibrillation
Population description:
Haemophilia patients (man, all severity)
Age above 50 years, followed during the last 5 years in one of the study centre
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| First group | – | Other: Non interventional studyHaemophilia patients with history of either cardiovascular disease or atrial fibrillation undergoing an antiplatelet or anticoagulant prophylaxis |
| Control group | – | Other: Non interventional studyHaemophilia patient without such history or treatment matched on age and disease status (haemophilia A or B and the severity of the disease : severe, mild, minor). |
Who may qualify
- Ages
- 50 years and older
- Sex
- Male only
- Age groups
- Adult, Older adult
- Study population
- Haemophilia patients (man, all severity) Age above 50 years, followed during the last 5 years in one of the study centre
Key inclusion criteria (4 listed)
- Male
- Age above 50 years
- Hemophilia A or B carriers
- Followed within the 5 last years in one of the research center
Key exclusion criteria (4 listed)
- Jurisdictional prevention procedures
- Other medical condition that might interfere with the bleeding risk (Willebrand's disease, Other coagulation factor deficiencies, haematological malignancies, …)
- Other drugs that might interfere with the bleeding risk (Serotonin reuptake inhibitors)
- Patient refusal
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 |
|---|---|---|
| Non interventional studyA query form to all concerned patients by each investigating centre will be send | Other | Control group, First group |
Primary outcome
Number of bleeding occurrences
Time frame: last 12 months
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 23 Jan 2020.
- Derived from this study: PubMed 30338508Desjonqueres A, Guillet B, Beurrier P, Pan-Petesch B, Ardillon L, Pineau-Vincent F, Sigaud M, Fouassier M, Ternisien C, Gillet B, Bene MC, Horvais V, Lienhart A, Trossaert M. Bleeding risk for patients with haemophilia under antithrombotic therapy. Results of the French multicentric study ERHEA. Br J Haematol. 2019 May;185(4):764-767. doi: 10.1111/bjh.15606. Epub 2018 Oct 18. No abstract available.
- 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.
Marc Trossaërt, Dr principal investigator
Nantes University Hospital
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hemophilia, run by Nantes University Hospital at 6 sites in France.
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 4 inclusion and 4 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 23 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 6 sites in France. 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?
Number of bleeding occurrences (time frame: last 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03157154, which also lists 1 linked publication.
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 23 Jan 2020.