Primary Objective: To compare the extent of haemolysis associated with the use of the conventional versus the miniaturised heart lung machine in the Amphia hospital, with the aim to set up evidence-based guidelines for the use of a specific type of…
ID
Source
Brief title
Condition
- Haemolyses and related conditions
- Coronary artery disorders
- Cardiac therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameter is the amount of haemolysis as examined by determining
cell free haem/cell free haemoglobin, haemoglobin, haematocrit and lactate
dehydrogenase.
Secondary outcome
Secondary study parameters are markers for the release of DAMPs (nucleosomes,
cell free DNA HMGB1), the activation of leukocytes (calprotectin) and
neutrophils (human neutrophil elastase-alpha1 antitrypsin complexes) and the
formation of neutrophil extracellular traps (myeloperoxidase(MPO)-nucleosome
complexes).
Background summary
Each year approximately eight thousand patients in the Netherlands undergo
coronary artery bypass grafting (CABG) surgery. . In the majority of cases a
heart-lung machine (HLM) is used for extracorporeal circulation (ECC). Two
different types of heart-lung machine set-ups are currently in use for CABG
surgery in the Amphia hospital; the conventional HLM and a miniaturised HLM. It
is known that contact of blood with the components of the HLM induces
haemolysis. We aim to collect data on the extent of haemolysis induced by each
type of HLM, as such information may be used for a more evidence based decision
in the use of a specific HLM and will potentially improve patient outcome.
Secondly, this study will focus on the release of damage associated molecular
patterns (DAMPs), leukocyte activation and neutrophil extracellular trap (NET)
formation induced by ECC. Leukocytes, including neutrophils, may be directly
activated after contact with the HLM, or as a consequence of the released
haemolytic breakdown products and the associated tissue damage. Since the HLM
is known to cause significant haemolysis during ECC, we will look for possible
correlations between haemolysis and the release of DAMPs, leukocyte activation
markers and markers of NET formation in patients undergoing CABG surgery.
Study objective
Primary Objective: To compare the extent of haemolysis associated with the use
of the conventional versus the miniaturised heart lung machine in the Amphia
hospital, with the aim to set up evidence-based guidelines for the use of a
specific type of heart-lung machine in CABG surgery.
Secondary Objectives: (1) To explore the extent of DAMPs release, leukocyte
activation and neutrophil extracellular trap release in patients undergoing
CABG surgery with extracorporeal circulation. (2) To determine whether direct
correlations exist between the extents of haemolysis on the one hand, and DAMPs
release, leukocyte activation and neutrophil extracellular trap release on the
other hand, in the context of the use of two types of heart-lung machines in
patients undergoing CABG surgery.
Study design
Prospective randomized cohort study.
Study burden and risks
A total of 72ml blood will be collected at six time point from patients
undergoing coronary artery bypass grafting procedures. There is at present no
evidence to suggest that participation in the study holds additional risk.
Patients are not positively or negatively affected when participating in this
study. No additional venepuncture is needed for blood collections.
Molengracht 21
Breda 4818 CK
NL
Molengracht 21
Breda 4818 CK
NL
Listed location countries
Age
Inclusion criteria
Elective CABG operation with extracorporeal circulation
Exclusion criteria
o Kidney insufficiency: creatinine >150 µmol/L
o Liver insufficiency: ASAT >80 U/L
o Left ventricular function (LVF): <30% Ejection fraction (EF)
o Body surface area (BSA): <1.6; *2.1 m²
o Carotid artery stenosis
o Pre-operative Haemoglobin: <7,5; *10 mmol/L
o Pre-operative red blood cell transfusion: <14 days before CABG procedure
o Splenectomy (influences the IgM levels used to determine the amount of haemodilution)
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 | NL59160.015.16 |