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Pro-inflammatory Cytokines in Blood From Orthopedic Surgery Compared to Abdominal Aneurysm Repair (KEEP-HB)

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ClinicalTrials.gov Identifier: NCT00851149
Recruitment Status : Unknown
Verified June 2010 by Sykehuset i Vestfold HF.
Recruitment status was:  Active, not recruiting
First Posted : February 25, 2009
Last Update Posted : June 11, 2010
Sponsor:
Collaborators:
Oslo University Hospital
Dentsply Sirona Implants
Information provided by:
Sykehuset i Vestfold HF

Brief Summary:
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)?

Condition or disease Intervention/treatment
Aortic Diseases Osteoarthritis, Hip Device: Sangvia blood sampling system

Detailed Description:

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.


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Study Type : Observational
Estimated Enrollment : 20 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Pro-inflammatory Cytokines (IL-1beta,IL-6, IL-8 and TNF-α) and Complement Activation (C3a) in Blood Collected From Surgery Field From Patients Undergoing Orthopedic Surgery Compared to Patients Undergoing Abdominal Aneurysm Repair.
Study Start Date : November 2009
Estimated Primary Completion Date : February 2010
Estimated Study Completion Date : May 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Aneurysms

Group/Cohort Intervention/treatment
1/10
Abdominal aortic surgery patients
Device: Sangvia blood sampling system
Blood collected from abdominal aortic repair patients are compared against blood collected from total hip replacement patients
Other Name: Sangvia Blood Salvage System

2/10
Total hip replacement patients
Device: Sangvia blood sampling system
Blood collected from abdominal aortic repair patients are compared against blood collected from total hip replacement patients
Other Name: Sangvia Blood Salvage System




Primary Outcome Measures :
  1. 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. [ Time Frame: 30 days ]

Secondary Outcome Measures :
  1. Haemoglobin, Trc, INR in blood samples and plasma will be analysed and compared between the 2 groups. [ Time Frame: 30 days ]

Biospecimen Retention:   Samples With DNA
Blood


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Primary care clinic
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00851149


Locations
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Norway
Sykehuset i Vestfold HF
Tonsberg, Norway, 3103
Sponsors and Collaborators
Sykehuset i Vestfold HF
Oslo University Hospital
Dentsply Sirona Implants
Investigators
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Principal Investigator: Espen Lindholm, Md Sykehuset i Vestfold HF

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Responsible Party: Espen Lindholm/Consultant, Hospital in Vestfold HF
ClinicalTrials.gov Identifier: NCT00851149     History of Changes
Other Study ID Numbers: 6.2009.36
First Posted: February 25, 2009    Key Record Dates
Last Update Posted: June 11, 2010
Last Verified: June 2010
Keywords provided by Sykehuset i Vestfold HF:
aorta
disease
abdominal
surgery
Osteoarthritis, Hip
replacement
blood
autolog
transfusion
cytokines
Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Hip
Aneurysm
Aortic Diseases
Aortic Aneurysm, Abdominal
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Vascular Diseases
Cardiovascular Diseases
Aortic Aneurysm