Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
101 participants
OBSERVATIONAL
2012-06-30
2015-05-31
Brief Summary
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Detailed Description
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Surgical and interventional therapy for aortic valve stenosis exposes the patients to a immune reaction, which is different depending on the type of the treatment. In this study, the investigators would like to better understand the inflammatory and antiinflammatory response in this patient population by monitoring the perioperative cytokine response (interleukins), the human leukocyte antigen expression (HLA-DR) and assessing soluble plasma factors (CD62L) involved in inflammatory processes.
Objective
Characterisation of inflammatory and antiinflammatory response in patients receiving aortic valve prosthesis selected for different treatment options.
Methods
Whole blood analysis at different time points (preoperatively, 4 / 24 /48 hours postoperatively) for different inflammatory and antiinflammatory markers: IL-6, IL-8, IL-10, CRP, TNF, soluble CD62L.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Minimized extracorporeal circulation
Patients with severe aortic valve stenosis undergoing surgical aortic valve replacement using the minimized extracorporeal circulation (MECC, group 1)
Whole blood analysis
In all fours groups of patients we investigate inflammatory and antiinflammatory response to the surgical and interventional treatment by analyzing changes in the concentration of interleukins, C-reactive protein, soluble CD62L and HLA-DR.
Conventional extracorporeal circulation
Patients with severe aortic valve stenosis undergoing surgical aortic valve replacement using the conventional extracorporeal circulation (CECC, group 2)
Whole blood analysis
In all fours groups of patients we investigate inflammatory and antiinflammatory response to the surgical and interventional treatment by analyzing changes in the concentration of interleukins, C-reactive protein, soluble CD62L and HLA-DR.
Transcatheter aortic valve implantation, transfemoral access
Patients with severe aortic valve stenosis undergoing transcatheter aortic valve implantation using the transfemoral access route
Whole blood analysis
In all fours groups of patients we investigate inflammatory and antiinflammatory response to the surgical and interventional treatment by analyzing changes in the concentration of interleukins, C-reactive protein, soluble CD62L and HLA-DR.
Transcatheter aortic valve implantation, transapical access
Patients with severe aortic valve stenosis undergoing transcatheter aortic valve implantation using the transapical access route
Whole blood analysis
In all fours groups of patients we investigate inflammatory and antiinflammatory response to the surgical and interventional treatment by analyzing changes in the concentration of interleukins, C-reactive protein, soluble CD62L and HLA-DR.
Interventions
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Whole blood analysis
In all fours groups of patients we investigate inflammatory and antiinflammatory response to the surgical and interventional treatment by analyzing changes in the concentration of interleukins, C-reactive protein, soluble CD62L and HLA-DR.
Eligibility Criteria
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Inclusion Criteria
* Severe aortic valve stenosis
* Surgical aortic valve replacement
* Transcatheter aortic valve implantation
* No previous inflammatory condition
Exclusion Criteria
* Treatment with corticosteroids
* Treatment with antibiotics
18 Years
90 Years
ALL
No
Sponsors
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Insel Gruppe AG, University Hospital Bern
OTHER
Responsible Party
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Principal Investigators
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Frank Stüber, MD, Prof.
Role: STUDY_DIRECTOR
Dep. Anesthesiology and pain Therapy
Locations
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Dep. Anesthesiology and Pain Therapy
Bern, , Switzerland
Countries
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Other Identifiers
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041/09_2
Identifier Type: -
Identifier Source: org_study_id
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