Demonstrate the possible difference in complications and bypass patency in certain large arterial operations with regard to the expression of the MBL-genotype.• Femoral/Crural
ID
Source
Brief title
Condition
- Arteriosclerosis, stenosis, vascular insufficiency and necrosis
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The outcome were we will be particularly focus on are the genotype of MBL. Next
to this are the post-operative complications (wound infections, re-operations,
amputations etc.) correlated.
Secondary outcome
Possible secundair outcomes values are, recovery measured in time and
eventually longer term comlications.
Background summary
In literature (see reference) the following things arise:
o Associations between MBL-deficiency and increased chance for infectious
diseases are reported, also in healthy patients.
o Also stronger in patients with co-morbidities such as immunological disorders
or chronic illness.
o These patients of MBL-deficiency have an increased chance for post-operative
wondinfections and surgical complications.
o Patients undergoing a livertransplant, where the liver has the favorablde
genotype, direct after surgery they show increased values in serum.
o This is also the other way around, so if the patient first has high
expression, but the liver low expression. Direct after surgery the quantity in
serum drops. This both is subject to to the fact that production takes places
in the liver.
o The MBL-pathway provides activation of the classical pathway of the immune
system respons, so if some patient is immune compromised en there is a lower
expression of the MBL-pathway these patients have increased risk for
complications
o Mutation in the MBL-gene have a significante negative impact on chronic
illness, like reumatoid arthritis, SLE and cystic fibrosis, which results in
increased incidence of complicated infections an worse outcome.
o The protective rol of MBL against infections can be explained by the direct
binding of MBL to Micro-organisms.
o The concentration of MBL is many times higher in new onset diabetic in
comparison with similar study patients.
o MBL is associated with vascular complications in diabetics, certain genotypes
are significant more vulnerable to nefropathy
o In short, MBL can be associated with the pathogenesis of microvasculair
complications.
Study objective
Demonstrate the possible difference in complications and bypass patency in
certain large arterial operations with regard to the expression of the
MBL-genotype.
• Femoral/Crural
Study design
patients undergoing a great arterial operation (Femoral/Crural). In front we
will obtain informed consent and pre-operative we will obtain one bloodsample
of heparenized blood for determining of the genotype. This determination will
be done in de laboratorium.
All patients will be classified to risk factors, such as Diabetic mellilitis,
smoking, cardi-vasculair diseases. Results from the research will be treated
anonymous and confidential.
Study burden and risks
Considering that every patient pre-operative will get a infuse, there will not
be any additional risk, while through this venous input on-off a heparinized
serum sample for determining the MBL-genotype. In short there will not be any
extra invasive action be carried out.
Hoograamstraat 113
6211BJ Maastricht
NL
Hoograamstraat 113
6211BJ Maastricht
NL
Listed location countries
Age
Inclusion criteria
Patients with an arterial operation, whereby we will differentiate between femoral and crural.
Exclusion criteria
None
Design
Recruitment
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 | NL40451.096.12 |