NCT03157154

Brief 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. 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
259

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2017

Shorter than P25 for all trials

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 16, 2017

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 17, 2017

Completed
1 month until next milestone

Study Start

First participant enrolled

June 27, 2017

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2017

Completed
Last Updated

January 23, 2020

Status Verified

January 1, 2020

Enrollment Period

1 month

First QC Date

May 16, 2017

Last Update Submit

January 22, 2020

Conditions

Hemophilia

Keywords

HaemophiliaAtherosclerosisAtrial fibrillationAntiplateletsAnticoagulant

Outcome Measures

Primary Outcomes (1)

  • Number of bleeding occurrences

    last 12 months

Study Arms (2)

First group

Haemophilia patients with history of either cardiovascular disease or atrial fibrillation undergoing an antiplatelet or anticoagulant prophylaxis

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).

Other: Non interventional study

Interventions

Non interventional studyOTHER

A query form to all concerned patients by each investigating centre will be send

Control groupFirst group

Eligibility Criteria

Age50 Years+
Sexmale
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Haemophilia patients (man, all severity) Age above 50 years, followed during the last 5 years in one of the study centre

You may qualify if:

  • Male
  • Age above 50 years
  • Hemophilia A or B carriers
  • Followed within the 5 last years in one of the research center

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Angers University Hospital

Angers, 49933, France

Location

Brest University Hospital

Brest, 29609, France

Location

Le Mans Hospital

La Mans, 72037, France

Location

Lyon University Hospital

Lyon, 69000, France

Location

Rennes University Hospital

Rennes, 35033, France

Location

Tours University Hospital

Tours, 37170, France

Location

Related Publications (1)

  • 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.

    PMID: 30338508DERIVED

MeSH Terms

Conditions

Hemophilia AAtherosclerosisAtrial Fibrillation

Condition Hierarchy (Ancestors)

Blood Coagulation Disorders, InheritedBlood Coagulation DisordersHematologic DiseasesHemic and Lymphatic DiseasesCoagulation Protein DisordersHemorrhagic DisordersGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular DiseasesArrhythmias, CardiacHeart DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Marc Trossaërt, Dr

    Nantes University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 16, 2017

First Posted

May 17, 2017

Study Start

June 27, 2017

Primary Completion

July 30, 2017

Study Completion

July 30, 2017

Last Updated

January 23, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share

Locations

FR(6)