Inflammatory Response in Aortic Valve Replacement

NCT ID: NCT02324140

Last Updated: 2015-07-14

Study Results

Results pending

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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Recruitment Status

COMPLETED

Total Enrollment

101 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-06-30

Study Completion Date

2015-05-31

Brief Summary

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The study investigates inflammatory and antiinflammatory response in patients with severe aortic valve stenosis needing either surgical treatment (surgical aortic valve replacement) or interventional cardiology treatment (transcatheter aortic valve implantation using the transfemoral access route or the transapical access route).

Detailed Description

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Background

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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Inflammation Systemic Inflammatory Response Syndrome Thoracic Surgery Aortic Valve Stenosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

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

Intervention Type OTHER

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

Intervention Type OTHER

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

Intervention Type OTHER

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

Intervention Type OTHER

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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Written informed consent
* Severe aortic valve stenosis
* Surgical aortic valve replacement
* Transcatheter aortic valve implantation
* No previous inflammatory condition

Exclusion Criteria

* Missing informed consent
* Treatment with corticosteroids
* Treatment with antibiotics
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Insel Gruppe AG, University Hospital Bern

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status

Countries

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Switzerland

Other Identifiers

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041/09_2

Identifier Type: -

Identifier Source: org_study_id

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