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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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German Clinical Trials Register |
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Last refreshed on:
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8 April 2024 |
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Main ID: |
DRKS00008855 |
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Date of registration:
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25/06/2015 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Influence of a minimized extracorporeal circulation on angiopoietin-1 and -2, and other markers of endothelial activation, a diagnostic study
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Scientific title:
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Influence of a minimized extracorporeal circulation on angiopoietin-1 and -2, and other markers of endothelial activation, a diagnostic study - / |
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Date of first enrolment:
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06/08/2015 |
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Target sample size:
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150 |
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Recruitment status: |
Complete |
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URL:
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http://drks.de/search/en/trial/DRKS00008855 |
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Study type:
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observational |
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Study design:
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Allocation: ; Masking: ; Control: ; Assignment: ; Study design purpose: diagnostic
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Phase:
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Countries of recruitment
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Germany
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Contacts
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Name:
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Johannes
Hadem |
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Address:
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Leipziger Str. 44
39120
Magdeburg
Germany |
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Telephone:
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+49-391-6714132 |
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Email:
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johannes.hadem@med.ovgu.de |
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Affiliation:
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Universitätsklinik für Herz- und Thoraxchirurgie |
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Name:
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Johannes
Hadem |
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Address:
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Leipziger Str. 44
39120
Magdeburg
Germany |
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Telephone:
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+49-391-6714132 |
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Email:
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johannes.hadem@med.ovgu.de |
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Affiliation:
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Universitätsklinik für Herz- und Thoraxchirurgie |
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Key inclusion & exclusion criteria
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Inclusion criteria: - Coronary of extracorporeal circulation
- Age> 18 years
- Written consent
Exclusion criteria: - Pre-existing rheumatic or chronic infectious disease (such as systemic lupus erythematosus, ANCA-positive vasculitis, rheumatoid arthritis, etc.)
- Certain medications (cortisol, immunosuppressants, ongoing oncological therapy)
- major surgery in the last 3 months
- renal insufficiency stage 3 or higher (GFR <60ml / min)
Age minimum:
18 Years
Age maximum:
None
Gender:
All
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Health Condition(s) or Problem(s) studied
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I25.13
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I25.13
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Intervention(s)
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Group 1: In patients with the need for coronary bypass surgery EDTA blood (plasma) is taken at the following times:
a. before connecting to the extracorporeal circulation (after opening the pericardium during OPCAB)
b. following the departure of the extracorporeal circulation,
c. 24 hours after departure from extracorporeal circulation and
d. 72h after disposal of extracorporeal circulation.
The samples are stored at -80 ° C and there is a measure of angiopoietin-1 and -2 (and possibly other inflammatory marker) by ELISA to an evaluation of the parameters collected for significant differences between the groups CPB, OPCAB and MPC.
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Primary Outcome(s)
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Diagnosis of angiopoietin-1 and -2 as well as other inflammatory and endothelial marker
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Secondary Outcome(s)
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- Vital and laboratory values of the first 72h
- fluid balance of the first 72 hours
- Katecholamindosen the first 72h
- organ dysfunction (Sequential Organ Failure Assessment [SOFA] and other scores)
- consumption of blood products
- hospital stays and intensive care hospital
- survival
- Quality of Life
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Secondary ID(s)
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U1111-1171-2959
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Source(s) of Monetary Support
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Universitätsklinik für Herz- und Thoraxchirurgie
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Ethics review
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Status: Approved
Approval date: 29/04/2015
Contact:
ethikkommission@ovgu.de
Ethik-Kommission der Otto-von-Guericke-Universität an der Medizinischen Fakultät und am Universitätsklinikum Magdeburg A.ö.R.
+49-391-6714314
ethikkommission@ovgu.de
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