Pro-inflammatory Cytokines in Blood From Orthopedic Surgery Compared to Abdominal Aneurysm Repair
KEEP-HB
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.
1 other identifier
observational
20
1 country
1
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)?
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Nov 2009
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 23, 2009
CompletedFirst Posted
Study publicly available on registry
February 25, 2009
CompletedStudy Start
First participant enrolled
November 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2010
CompletedJune 11, 2010
June 1, 2010
3 months
February 23, 2009
June 10, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (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.
30 days
Secondary Outcomes (1)
Haemoglobin, Trc, INR in blood samples and plasma will be analysed and compared between the 2 groups.
30 days
Study Arms (2)
1/10
Abdominal aortic surgery patients
2/10
Total hip replacement patients
Interventions
Blood collected from abdominal aortic repair patients are compared against blood collected from total hip replacement patients
Eligibility Criteria
Primary care clinic
You may qualify if:
- ASA 1-4
You may not qualify if:
- 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
- Acute abdominal aortic surgery (acute dissection or rupture)
- Planned laparoscopic abdominal aortic aneurysm surgery
- Transfusion of blood products last month before surgery
- Glucocorticoid users
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sykehuset i Vestfold HFlead
- Oslo University Hospitalcollaborator
- Dentsply Sirona Implants and Consumablescollaborator
Study Sites (1)
Sykehuset i Vestfold HF
Tønsberg, 3103, Norway
Biospecimen
Blood
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Espen Lindholm, Md
Sykehuset i Vestfold HF
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
February 23, 2009
First Posted
February 25, 2009
Study Start
November 1, 2009
Primary Completion
February 1, 2010
Study Completion
May 1, 2010
Last Updated
June 11, 2010
Record last verified: 2010-06