Proteomics in Multiple Trauma to Identify Organ Failure | NCT02030327

Studies
Proteomics in Multiple Trauma to Identify Organ Failure

NCT02030327

Sponsor

Universitätsklinikum Köln

Status

Unknown status

Last Update Posted

May 17, 2022Actual

Enrollment

85Estimated

Phase

Not provided

Conditions

Multiple Trauma

Interventions

Not provided

Countries

Germany

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

May 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2014

Primary Completion Date

Dec 2022Estimated

Completion Date

Dec 2022Estimated

First Submitted Date

Jan 2, 2014

First Submission Date that Met QC Criteria

Jan 6, 2014

First Posted Date

Jan 8, 2014Estimated

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

May 16, 2022

Last Update Posted Date

May 17, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Jochen Hinkelbein, Priv.-Doz. Dr. med., Universitätsklinikum KölnPrincipal Investigator

Lead Sponsor

Universitätsklinikum KölnOTHER

Collaborators

Not provided

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

To analyse differences in protein expression in multiple trauma patients for identification of potential biomarkers to predict organ dysfunction.

Detailed Description

The aim of the present study in humans is to analyse differences in protein expression after multiple trauma in patients for identification of potential biomarkers to predict organ dysfunction.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

85Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
No trauma		n=5 patients
trauma without organ dysfunction		n=40 patients
trauma with organ dysfunction		n=40 patients

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of patients with disease or death vs. healthy	Starting at day O, then every 24 hours until day 20	Day 0 until day 20

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

older than 18 years
multiple trauma patients
ISS >16

Exclusion Criteria:

children
ISS <16

Accepts Healthy Volunteers

Yes

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

older than 18 years multiple trauma patients ISS >16

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jochen Hinkelbein, MD	UK Köln	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospital of Cologne	Recruiting	Cologne	North Rhine-Westphalia	50937	Germany

Condition Browse Module

MeSH Terms

ID	Term
D009104	Multiple Trauma

Ancestor Terms

ID	Term
D014947	Wounds and Injuries

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Browse Branches

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