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Clinical Trial Details — Status: Unknown status

Administrative data

NCT number NCT00851149
Other study ID # 6.2009.36
Secondary ID
Status Unknown status
Phase N/A
First received February 23, 2009
Last updated June 10, 2010
Start date November 2009
Est. completion date May 2010

Study information

Verified date June 2010
Source Sykehuset i Vestfold HF
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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)?


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.


Recruitment information / eligibility

Status Unknown status
Enrollment 20
Est. completion date May 2010
Est. primary completion date February 2010
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 a2-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 Design


Intervention

Device:
Sangvia blood sampling system
Blood collected from abdominal aortic repair patients are compared against blood collected from total hip replacement patients

Locations

Country Name City State
Norway Sykehuset i Vestfold HF Tonsberg

Sponsors (3)

Lead Sponsor Collaborator
Sykehuset i Vestfold HF Dentsply Sirona Implants, Oslo University Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type Measure Description Time frame Safety issue
Primary Pro-inflammatory cytokines (IL-6, IL-8 and TNF-a) and complement activation (C3a) in blood samples collected from surgery field. Comparison between the 2 groups. 30 days
Secondary Haemoglobin, Trc, INR in blood samples and plasma will be analysed and compared between the 2 groups. 30 days
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