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

Sponsor

Sykehuset i Vestfold HF (Other)

Overall Status

Unknown status

CT.gov ID

NCT00851149

Collaborator

Oslo University Hospital (Other), Dentsply Sirona Implants (Industry)

Enrollment

Location

5.9

Duration (Months)

3.4

Patients Per Site Per Month

Study Details

Study Description

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	Phase
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.

Study Design

Study Type:

Observational

Anticipated 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 :

Nov 1, 2009

Anticipated Primary Completion Date :

Feb 1, 2010

Anticipated Study Completion Date :

May 1, 2010

Arms and Interventions

Arm	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

Arm

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

Outcome Measures

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. [30 days]

Secondary Outcome Measures

Haemoglobin, Trc, INR in blood samples and plasma will be analysed and compared between the 2 groups. [30 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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