Aortic DiseasesKEEP-HBNCT00851149
Pro-inflammatory Cytokines in Blood From Orthopedic Surgery Compared to Abdominal Aneurysm Repair
An observational study of Aortic Diseases and Osteoarthritis, Hip, run by Sykehuset i Vestfold HF at 1 site in Norway.
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)? Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Diseases, Osteoarthritis, Hip
- What is being tested?
- Sangvia blood sampling system
- Type of treatment
- Medical device
- How many people
- 20 participants
- Where
- 1 siteNorway
- Study dates
- Nov 2009to May 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Primary care clinic
Who may be able to join
- ASA 1-4
Who cannot join
- 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
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- 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 locations and contacts
1 site in 1 country.
About this study
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.
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)?
Read the 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.
- Conditions
- Aortic Diseases, Osteoarthritis, Hip
- Being tested
- Sangvia blood sampling system
- Keywords
- aorta, disease, abdominal, surgery, Osteoarthritis, Hip, replacement, blood, autolog, transfusion, cytokines
- Medical subject headings
- Aortic Diseases, Osteoarthritis, Hip, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sangvia blood sampling systemDevice
Also called Sangvia Blood Salvage System
Blood collected from abdominal aortic repair patients are compared against blood collected from total hip replacement patients
| Study group | Role | What they receive |
|---|---|---|
| 1/10 | Abdominal aortic surgery patients Receives: Device: Sangvia blood sampling system | |
| 2/10 | Total hip replacement patients Receives: Device: Sangvia blood sampling system |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 30 days
Secondary outcomes (1)
Haemoglobin, Trc, INR in blood samples and plasma will be analysed and compared between the 2 groups.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2009 (estimated)
- Study startNov 2009
- Primary completionFeb 2010 (estimated)
- Study completionMay 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sykehuset i Vestfold HF
- Sponsor type
- University, hospital or other
- Collaborators
- Oslo University Hospital, Dentsply Sirona Implants and Consumables
- Investigators
- Espen Lindholm, Md, Principal investigator, Sykehuset i Vestfold HF
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00851149
- Sponsor's protocol ID
- 6.2009.36
- Acronym
- KEEP-HB
- Status last verified
- Jun 2010
- First submitted
- 23 Feb 2009
- Last updated
- 11 Jun 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT00851149
- Acronym / sponsor ID
- KEEP-HB / 6.2009.36
- Conditions
- Aortic Diseases, Osteoarthritis, Hip
- Keywords
- aorta, disease, abdominal, surgery, Osteoarthritis, Hip, replacement, blood, autolog
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Sykehuset i Vestfold HFUniversity, hospital or other
- Collaborators
- Oslo University Hospital, Dentsply Sirona Implants and Consumables
- Study start
- Nov 2009
- Primary completion
- Feb 2010 (estimated)
- Study completion
- May 2010 (estimated)
- First posted
- 25 Feb 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)?
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
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1/10 | – | Device: Sangvia blood sampling systemAbdominal aortic surgery patients |
| 2/10 | – | Device: Sangvia blood sampling systemTotal hip replacement patients |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Primary care clinic
Key inclusion criteria (1 listed)
- ASA 1-4
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sangvia blood sampling systemAlso: Sangvia Blood Salvage SystemBlood collected from abdominal aortic repair patients are compared against blood collected from total hip replacement patients | Device | 1/10, 2/10 |
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.
Time frame: 30 days
1 secondary outcome
Haemoglobin, Trc, INR in blood samples and plasma will be analysed and compared between the 2 groups.
Time frame: 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Espen Lindholm, Md principal investigator
Sykehuset i Vestfold HF
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aortic Diseases and Osteoarthritis, Hip, run by Sykehuset i Vestfold HF at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Jun 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2010.