Development
of an International Database on Rare Bleeding Disorders (RBDD)
INFORMATION
BOOKLET FOR PARTICIPANTS IN THE STUDY
What
is the aim of this study?
Rare bleeding disorders (fibrinogen deficiency, prothrombin deficiency
and factor V, V+VIII, VII, X, XI and XIII deficiencies) are rare
hemorrhagic syndromes with prevalence in the general population
varying between 1 in 500,000 and 1 in 1,000,000. Families with
a coagulation factor deficiency can have different clinical expression.
Patients with a severe deficiency of a coagulation factor generally
have hemorrhagic symptoms as severe post-operative or post-dental
extraction bleeding, ecchymosis, epistaxis, haematoma and hemarthrosis
or umbilical cord bleeding and in more severe cases central nervous
system bleeding and gastrointestinal bleeding. Patients' families
could have a milder deficiency and could be completely asymptomatic.
Up to date diagnosis is based on laboratory tests that measure
the coagulation factor activity in the blood. Since these disorders
are rare and heterogeneous and their clinical and biological characteristics
are not perfectly known, an International Database on Rare Bleeding
Disorders has been carried out (RBDD) to collect all obtained
data from patients participating in the study and from their families.
The aim of the study you are asked to participate in is to develop
this database (since up to date such a database doesn't exist).
It will make possible to use clinical and treatment data obtained
from clinical practice.
With information obtained from RBDD it will be possible to improve
clinical diagnosis and rare bleeding disorders treatment and to
provide the best advice for prenatal diagnosis.
At this aim we are going to:
- take a blood sample to measure coagulation factor deficiency
and to extract DNA. DNA extraction will be useful for genetic
research that will be carry out only in case of suspected congenital
deficiency (i.e. transmitted in the family). Research of mutations
will be performed according to provided information about relationship.
If information is not right Centre____________________________________
and its staff will not be legally responsible for inaccurate diagnosis.
A part of blood sample will be used for above-said dosages; another
part will be frozen and kept in anonymous form with clinical and
laboratory data, plasma samples and extracted DNA.
- put in RBDD all laboratory data and all information provided
from patients during the interview
- use for statistics only clinical and laboratory data and we
are not going to use sensible medical data which could identify
the patient (name, surname, address, telephone number, taxpayer's
code number, religion, etc.)
Could
there be any risk or discomfort for participants?
The only discomfort that could be for participants is due to a
normal taking of blood sample. Taking blood could cause slight
pain due to the needle and could provoke little hemorrhages or
ecchymosis.
What
does participation in the study involve?
If you agree to participate in this study you will have to provide
some information about your clinic history and your health problems.
At the beginning of the study blood sample will be taken. Further
sample of blood could be required if first sample is not enough
or unsuitable or corrupted. Some others relatives of you could
be asked to participate in the study.
Can I withdraw from the study whenever I want?
Yes. Your participation in the study is completely voluntary so
that you can withdraw from it at any time asking for the destruction
of your biological samples. If you decide to withdraw your consent
or your participation in the study there WILL NOT BE ANY NEGATIVE
CONSEQUENCES on your treatment or on any other medical procedure
concerning you.
Will you inform me about every possible finding?
If, as a result of this study, it will be identify the genetic
defect responsible for your bleeding disorder, and if it will
be possible to perform genetic advice and prenatal diagnosis and
if important new information emerges during your participation,
we could trace back to your identity thank to your numeric code
and you will be informed about analysis outcomes. Analysis outcomes
will be given in writing absolutely only to undersigned. Participant's
analysis outcomes will be kept with the ones of his family in
diagnosis centre on magnetic storage medium with the aim to conserve
them for future
| How
my samples will be kept? |
| All your
samples (plasma and DNA) will be kept on the responsibility
of Dr._______________________ |
| from
treatment centre _________________________ _______________________________________ |
| address
________________________________ City _________________Country________________
|
| during
all the study. |
Will
obtained information be confidential?
Yes. We will refer to you and to your samples only by an identification
code assigned at the beginning of the study. All information about
you will be confidential, on the responsibility of Prof. Flora
Peyvandi at Hemophilia and Thrombosis Centre, Via Pace 9, 20122
Milan, Italy.
Is
this consent valid only for this study?
Yes. You can decide to participate in others studies if obtained
results will be useful for further therapeutic and diagnostic
uses. In this case you can authorize this centre or others academic
centres to use your biological samples. In any case other centres
will not receive any of your sensible data and they will have
only anonymous codes.
Will
you pay me for my participation?
No, your decision to take part in this study is absolutely free.
| Who
can I contact if I need further information? |
| For further
information about clinical and treatment you can contact Dr.______________________ |
| at Treatment
Centre________________________Address________________________________ |
| City,
Country _____________________________ telephone___________________________ |
| For any
questions about storage and use of data and about their insertion
in RBDD, you can contact Prof. Peyvandi at Hemophilia and
Thrombosis Centre- Via Pace 9, 20122 Milan, Italy- tel. 02-55035414
or 02-55034460 |
How
can I do if I'd have to complain for the study management?
If you need you could complain to complaint department of clinical
structures that participate in the study. Your participation in
the study will not restrict your complaint right in any way.
Development of an International Database on Rare Bleeding Disorders
(RBDD)
Information consent pursuant to Law 675 of 31.12.1996 on the protection
of personal data.
| I, the
undersigned ___________________________________ born in ___________________ |
| On ___________
resident in ___________________________street ____________________ |
| Tel.______________________________
Forwarding clinician or ward ___________________ |
|
DECLARE that
I received exhaustive explanations regarding the request
to take part in the study referred to above and that I understood
all explanations.
Consequently, I freely decide to take part in the study
and I give my consent to "Development of an International
Database on Rare Bleeding Disorders (RBDD)" and I give
my consent to:
|
| |
blood taking
to measure deficient plasmatic factor using a standardized
method reported in international literature
|
| |
molecular characterisation
of genetic defect through DNA analysis using standardized
protocol reported in international literature |
| |
conservation
of biological samples conforming to study protocol,
|
| |
the use of my
clinical and laboratory data and to their insertion in RBDD
for the purpose of scientific research (included their publication),
in a strictly anonymous form and with the assurance that
my biological samples will be used exclusively for the purpose
of this study.
|
| |
agree since now
to others studies carried out at Luigi Villa Foundation, that
has an agreement with IRCCS Foundation, Ospedale Maggiore
Policlinico di Milano, Mangiagalli e Regina Elena, if outcomes
are going to be interesting for further therapeutic and diagnostic
uses. |
| |
agree since now
to others studies carried out at others academic or research
centres (in any case other centres will not receive any
of my sensible data and they will have only my anonymous
code), if outcomes are going to be interesting for further
therapeutic and diagnostic uses.
|
| |
I moreover DECLEAR
that I have been informed that:
|
| |
I can withdraw
from this study at any time asking for the destruction of
my biological samples. |
| |
I, the undersigned
_____________________________ declare that on this day I have
been informed about laws in force regarding privacy of personal
data (especially of sensible medical data) (art n. 13 concerned
person's rights, n. 22 sensible data, n.23 medical data) and
that I understand that it is obligatory providing required
data and acquiring data emerging during the study. |
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Date ........................................... |
Signature ........................................... |
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