Inflammation and Infection in Trauma, Role in Posttraumat... | NCT00192907

Studies
Inflammation and Infection in Trauma, Role in Posttraumatic Complications

NCT00192907

Sponsor

Rigshospitalet, Denmark

Status

Unknown status

Last Update Posted

Sep 19, 2005Estimated

Enrollment

380

Phase

Not provided

Conditions

Trauma

Interventions

Not provided

Countries

Denmark

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

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2005

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

Mar 2003

Primary Completion Date

Not provided

Completion Date

Sep 2005

First Submitted Date

Sep 12, 2005

First Submission Date that Met QC Criteria

Sep 16, 2005

First Posted Date

Sep 19, 2005Estimated

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

Sep 16, 2005

Last Update Posted Date

Sep 19, 2005Estimated

Description Module

Brief Summary

The purpose of this study is to investigate the relationship between trauma, the immune system, biochemical changes in the first 24 h and subsequent complications and mortality

Detailed Description

The immune system plays a role in the development of complications after severe trauma, but we do not know how. Equally, biochemical changes measured in the blood after trauma (eg. bloodglucose, GC-globulin, coagulation parameters etc.) may predict the prognosis and the degree of complcations. Two significant complications are infection and organ failure, which may prolong hospitalisation and increase mortality.

In the study we collected samples from blood and body surfaces to determine changes in cytokines, biochemistry, bacterial flora, and subsequent complications. We compare the changes in between groups of the cohort.

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

No data available

No data is available for this block.

Enrollment

380

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Clinical suspicion of multiple trauma
Age >/= 18 years
Direct referral from scene of accident

Exclusion Criteria:

Major burn injury
HIV positiv
Pregnancy

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

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jakob Stensballe, MD	Rigshospitalet, Denmark	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Rigshospitalet, Copenhagen University Hospital		Dk-2100 Copenhagen			Denmark

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
21772125	Derived	Johansson PI, Stensballe J, Rasmussen LS, Ostrowski SR. A high admission syndecan-1 level, a marker of endothelial glycocalyx degradation, is associated with inflammation, protein C depletion, fibrinolysis, and increased mortality in trauma patients. Ann Surg. 2011 Aug;254(2):194-200. doi: 10.1097/SLA.0b013e318226113d.