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Main
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Note: This record shows only the 20 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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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00851149 |
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Date of registration:
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23/02/2009 |
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Primary sponsor: |
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Public title:
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Pro-inflammatory Cytokines in Blood From Orthopedic Surgery Compared to Abdominal Aneurysm Repair
KEEP-HB |
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Scientific title:
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Pro-inflammatory Cytokines (IL-1beta,IL-6, IL-8 and TNF-a) and Complement Activation (C3a) in Blood Collected From Surgery Field From Patients Undergoing Orthopedic Surgery Compared to Patients Undergoing Abdominal Aneurysm Repair. |
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Date of first enrolment:
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November 2009 |
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Target sample size:
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20 |
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Recruitment status: |
Active, not recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT00851149 |
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Study type:
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Observational |
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Study design:
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Observational Model: Case Control, Time Perspective: Prospective
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Countries of recruitment
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Norway
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Contacts
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Name:
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Espen Lindholm, Md |
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Address:
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Telephone:
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Email:
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Affiliation:
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Sykehuset i Vestfold HF |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- ASA 1-4
Exclusion Criteria:
- Patient using corticosteroids, NSAIDs or Cox-II inhibitors
- Patients under 18 years
- Patients who are included in pharmaceutical studies
- Opioids-, benzodiazepines-, antiepileptic drugs-, alcohol- and a2-agonists abuse
- Pregnant and breastfeeding women
- Patients with known hypersensitivity for opioids, propofol or volatile anesthetics
- Patients with serious arrhythmias (atrial fibrillation/flutter is acceptable)
- Uncontrolled hypertension, serious psychiatric disease
- Patients with unstable angina pectoris or myocardial infarction the last month before
inclusion
- Acute abdominal aortic surgery (acute dissection or rupture)
- Planned laparoscopic abdominal aortic aneurysm surgery
- Transfusion of blood products last month before surgery
- Glucocorticoid users
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Aortic Diseases
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Osteoarthritis, Hip
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Intervention(s)
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Device: Sangvia blood sampling system
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Primary Outcome(s)
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Pro-inflammatory cytokines (IL-6, IL-8 and TNF-a) and complement activation (C3a) in blood samples collected from surgery field. Comparison between the 2 groups.
[Time Frame: 30 days]
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Secondary Outcome(s)
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Haemoglobin, Trc, INR in blood samples and plasma will be analysed and compared between the 2 groups.
[Time Frame: 30 days]
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Secondary ID(s)
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6.2009.36
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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