Pro-inflammatory Cytokines in Blood From Orthopedic Surgery Compared to Abdominal Aneurysm Repair

NCT ID: NCT00851149

Last Updated: 2010-06-11

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

UNKNOWN

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-11-30

Study Completion Date

2010-05-31

Brief Summary

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The purpose of this study is to investigate the contents in blood sampled from surgery site during hip replacement compared with blood sampled from abdominal aortic surgery. Is there any difference in pro-inflammatory cytokines (IL-1beta, IL-6, IL-8 and TNF-α), complement activation (C3a)?

Detailed Description

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Patient (n= 10) scheduled for total hip replacement or hemiprosthesis and patient (n=10) scheduled for abdominal aortic surgery.

Primary outcome:

Pro-inflammatory cytokines (IL-6, IL-8 and TNF-α) and complement activation (C3a) in blood samples collected from surgery field. Comparison between the 2 groups.

Secondary outcome:

Haemoglobin, Trc, INR in blood samples and plasma will be analysed and compared between the 2 groups.

Conditions

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Aortic Diseases Osteoarthritis, Hip

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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1/10

Abdominal aortic surgery patients

Sangvia blood sampling system

Intervention Type DEVICE

Blood collected from abdominal aortic repair patients are compared against blood collected from total hip replacement patients

2/10

Total hip replacement patients

Sangvia blood sampling system

Intervention Type DEVICE

Blood collected from abdominal aortic repair patients are compared against blood collected from total hip replacement patients

Interventions

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Sangvia blood sampling system

Blood collected from abdominal aortic repair patients are compared against blood collected from total hip replacement patients

Intervention Type DEVICE

Other Intervention Names

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Sangvia Blood Salvage System

Eligibility 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 α2-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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Oslo University Hospital

OTHER

Sponsor Role collaborator

Dentsply Sirona Implants and Consumables

INDUSTRY

Sponsor Role collaborator

Sykehuset i Vestfold HF

OTHER

Sponsor Role lead

Responsible Party

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Hospital in Vestfold HF

Principal Investigators

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Espen Lindholm, Md

Role: PRINCIPAL_INVESTIGATOR

Sykehuset i Vestfold HF

Locations

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Sykehuset i Vestfold HF

Tønsberg, , Norway

Site Status

Countries

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Norway

Other Identifiers

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6.2009.36

Identifier Type: -

Identifier Source: org_study_id

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