The purpose of the HiN-6 study is:(1) To describe the health status of the Dutch haemophilia population, with special focus on viral infections, inhibitor development and age-related co-morbidities.(2) To gain insight into the health-related quality…
ID
Source
Brief title
Condition
- Coagulopathies and bleeding diatheses (excl thrombocytopenic)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Presence of disease-related co-morbidities, health-related quality of life,
quality of care, self-reported bleeding severity, self-reported joint function
and the presence of inhibitors, non-neutralizing antibodies and immunological
markers.
Secondary outcome
Not applicable
Background summary
There is little information on the current health status of the Dutch
haemophilia population, especially ageing patients, HIV/HCV patients and
inhibitor patients. In addition, quality of life may be reduced in some persons
with haemophilia (PWH) despite similar levels of physical health. Furthermore,
differences in clinical phenotypes have been described in patients with
comparable coagulation factor activities. Lastly, inhibitor formation is still
an important complication in haemophilia treatment, a better understanding is
needed about the mechanisms that lead to inhibitor formation.
Study objective
The purpose of the HiN-6 study is:
(1) To describe the health status of the Dutch haemophilia population, with
special focus on viral infections, inhibitor development and age-related
co-morbidities.
(2) To gain insight into the health-related quality of life of PWH.
(3) To gain insight into the quality of care of PWH.
(4) To explain the variability in clinical phenotype among PWH.
(5) To gain insight into the mechanisms underlying the humoral and cellular
immune response to FVIII.
Study design
The HiN-6 study will consist of both cross-sectional and longitudinal
observational studies, according to the specific research objective. Some of
the collected patient material and clinical data will be used to set up a
biobank. Data will be collected from each participant*s medical record using
case report forms, through questionnaires filled in by each participant, by
blood sampling and by urine sampling.
Study burden and risks
The participants* burden consists of 1 or 2 blood draws, one urine collection
and filling in a questionnaire. No direct benefit is expected from
participation in this study. Participation in this study may have benefits for
future patients with haemophilia.
Albinusdreef 2
Leiden 2333ZA
NL
Albinusdreef 2
Leiden 2333ZA
NL
Listed location countries
Age
Inclusion criteria
- Men with severe, moderate, mild congenital haemophilia A or B that are
registered at one of the haemophilia treatment centres in the Netherlands.
- Written informed consent before data collection and sampling blood/urine.
- Male patients with congenital haemophilia A or B who underwent liver
transplantation in the past (irrespective of their endogenous clotting factor
levels)
- All currently deceased male haemophilia A or B patients that participated in
the HiN-5 questionnaire in 2001
Exclusion criteria
- Female carriers of haemophilia A or B
- Symptomatic carriers of haemophilia A or B
- Patients with acquired haemophilia.
- Patients with reduced FVIII levels due to Von Willebrand disease.
- Inability to obtain informed consent from patients older than 12 years of age.
- No informed consent before data collection and sampling blood/urine.
Design
Recruitment
metc-ldd@lumc.nl
metc-ldd@lumc.nl
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL59114.058.17 |