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

S

Sykehuset i Vestfold HF

Status

Unknown

Conditions

Osteoarthritis, Hip
Aortic Diseases

Treatments

Device: Sangvia blood sampling system

Study type

Observational

Funder types

Other
Industry

Identifiers

NCT00851149
6.2009.36

Details and patient eligibility

About

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)?

Full 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.

Enrollment

20 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No 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

Trial design

20 participants in 2 patient groups

1/10
Description:
Abdominal aortic surgery patients
Treatment:
Device: Sangvia blood sampling system
2/10
Description:
Total hip replacement patients
Treatment:
Device: Sangvia blood sampling system

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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