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

Pro-inflammatory Cytokines in Blood From Orthopedic Surgery Compared to Abdominal Aneurysm Repair (KEEP-HB)
The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2010 by Sykehuset i Vestfold HF.   Recruitment status was  Active, not recruiting

First Received on February 23, 2009.  
Last Updated on June 10, 2010  
History of Changes
Sponsor: Sykehuset i Vestfold HF
Collaborators: Oslo University Hospital
Astra Tech AB
Information provided by: Sykehuset i Vestfold HF
ClinicalTrials.gov Identifier: NCT00851149
  Purpose

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 Intervention
Aortic Diseases
Osteoarthritis, Hip
Device: Sangvia blood sampling system

Study Type: Observational
Study Design: 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.

Resource links provided by NLM:

Further study details as provided by Sykehuset i Vestfold HF:

Primary Outcome Measures:

  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

  • Haemoglobin, Trc, INR in blood samples and plasma will be analysed and compared between the 2 groups. [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]

Biospecimen Retention:   Samples With DNA

Blood

Estimated Enrollment: 20
Study Start Date: November 2009
Estimated Study Completion Date: May 2010
Estimated Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)

Groups/Cohorts

Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00851149

Locations
Norway
Sykehuset i Vestfold HF
Tonsberg, Norway, 3103
Sponsors and Collaborators
Sykehuset i Vestfold HF
Oslo University Hospital
Astra Tech AB
Investigators
Principal Investigator: Espen Lindholm, Md Sykehuset i Vestfold HF
  More Information

No publications provided

Responsible Party: Espen Lindholm/Consultant, Hospital in Vestfold HF
ClinicalTrials.gov Identifier: NCT00851149    
History of Changes
Other Study ID Numbers: 6.2009.36
Study First Received: February 23, 2009
Last Updated: June 10, 2010
Health Authority: Norway: Directorate for Health and Social Affairs
Norway: Norwegian Institute of Public Health
Norway: Norwegian Social Science Data Services
Norway: The National Committees for Research Ethics in Norway

Keywords provided by Sykehuset i Vestfold HF:

aorta
disease
abdominal
surgery
Osteoarthritis, Hip
replacement
blood
autolog
transfusion
cytokines

Additional relevant MeSH terms:

Aneurysm
Aortic Diseases
Osteoarthritis
Osteoarthritis, Hip
Aortic Aneurysm, Abdominal
Vascular Diseases
Cardiovascular Diseases
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Aortic Aneurysm

ClinicalTrials.gov processed this record on August 21, 2012

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