Overview

This trial is active, not recruiting.

Conditions aortic diseases, osteoarthritis, hip
Treatment sangvia blood sampling system
Sponsor Sykehuset i Vestfold HF
Collaborator Oslo University Hospital
Start date November 2009
End date February 2010
Trial size 20 participants
Trial identifier NCT00851149, 6.2009.36

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)?

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case control
Time perspective prospective
Arm
Abdominal aortic surgery patients
sangvia blood sampling system Sangvia Blood Salvage System
Blood collected from abdominal aortic repair patients are compared against blood collected from total hip replacement patients
Total hip replacement patients
sangvia blood sampling system Sangvia Blood Salvage System
Blood collected from abdominal aortic repair patients are compared against blood collected from total hip replacement patients

Primary Outcomes

Measure
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 Outcomes

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

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

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.
Principal investigator Espen Lindholm, Md
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.
Trial information was received from ClinicalTrials.gov and was last updated in June 2010.
Information provided to ClinicalTrials.gov by Sykehuset i Vestfold HF.