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

June 10, 2010 updated by: Sykehuset i Vestfold HF

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.

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)?

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Anticipated)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Tonsberg, Norway, 3103
        • Sykehuset I Vestfold HF

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Primary care clinic

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

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 Names:
  • 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 Names:
  • Sangvia Blood Salvage System

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
30 days

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sykehuset i Vestfold HF

Collaborators

Oslo University Hospital
Dentsply Sirona Implants

Investigators

  • Principal Investigator: Espen Lindholm, Md, Sykehuset I Vestfold HF

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2009

Primary Completion (Anticipated)

February 1, 2010

Study Completion (Anticipated)

May 1, 2010

Study Registration Dates

First Submitted

February 23, 2009

First Submitted That Met QC Criteria

February 23, 2009

First Posted (Estimate)

February 25, 2009

Study Record Updates

Last Update Posted (Estimate)

June 11, 2010

Last Update Submitted That Met QC Criteria

June 10, 2010

Last Verified

June 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 6.2009.36

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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