NCT02030327

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
85

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2014

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

January 2, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 8, 2014

Completed
8.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

May 17, 2022

Status Verified

May 1, 2022

Enrollment Period

8.9 years

First QC Date

January 2, 2014

Last Update Submit

May 16, 2022

Conditions

Multiple Trauma

Keywords

proteomicsmultiple traumaorgan dysfunction

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (3)

No trauma

n=5 patients

trauma without organ dysfunction

n=40 patients

trauma with organ dysfunction

n=40 patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

older than 18 years multiple trauma patients ISS \>16

You may qualify if:

  • older than 18 years
  • multiple trauma patients
  • ISS \>16

You may not qualify if:

  • children
  • ISS \<16

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital of Cologne

Cologne, North Rhine-Westphalia, 50937, Germany

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

serum (blood) and urine

MeSH Terms

Conditions

Multiple Trauma

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

  • Jochen Hinkelbein, MD

    UK Köln

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Priv.-Doz. Dr. med.

Study Record Dates

First Submitted

January 2, 2014

First Posted

January 8, 2014

Study Start

January 1, 2014

Primary Completion

December 1, 2022

Study Completion

December 1, 2022

Last Updated

May 17, 2022

Record last verified: 2022-05

Locations

DE(1)