Pro-inflammatory Cytokines in Blood From Orthopedic Surge... | NCT00851149

Studies
Pro-inflammatory Cytokines in Blood From Orthopedic Surgery Compared to Abdominal Aneurysm Repair

NCT00851149

Sponsor

Sykehuset i Vestfold HF

Status

Unknown status

Last Update Posted

Jun 11, 2010Estimated

Enrollment

20Estimated

Phase

Not provided

Conditions

Aortic Diseases
Osteoarthritis, Hip

Interventions

Sangvia blood sampling system

Countries

Norway

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2010

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2009

Primary Completion Date

Feb 2010Estimated

Completion Date

May 2010Estimated

First Submitted Date

Feb 23, 2009

First Submission Date that Met QC Criteria

Feb 23, 2009

First Posted Date

Feb 25, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 10, 2010

Last Update Posted Date

Jun 11, 2010Estimated

Name	Class
Oslo University Hospital	OTHER
Dentsply Sirona Implants and Consumables	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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)?

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

20Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1/10		Abdominal aortic surgery patients	Device: Sangvia blood sampling system
2/10		Total hip replacement patients	Device: Sangvia blood sampling system

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Sangvia blood sampling system	Device	Blood collected from abdominal aortic repair patients are compared against blood collected from total hip replacement patients	1/10

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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 Outcomes

Measure	Description	Time Frame
Haemoglobin, Trc, INR in blood samples and plasma will be analysed and compared between the 2 groups.		30 days

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Primary care clinic

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Espen Lindholm, Md	Sykehuset i Vestfold HF	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sykehuset i Vestfold HF		Tønsberg		3103	Norway

Type	Date	Date Unknown
Release	Dec 12, 2012
Reset	Jan 18, 2013

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Dec 12, 2012			Jan 18, 2013

Condition Browse Module

MeSH Terms

ID	Term
D001018	Aortic Diseases
D015207	Osteoarthritis, Hip
D004194	Disease

Ancestor Terms

ID	Term
D014652	Vascular Diseases
D002318	Cardiovascular Diseases
D010003	Osteoarthritis
D001168	Arthritis

Browse Leaves

Not provided

Browse Branches

Not provided