NCT02367768

Brief Summary

The investigators were looking for resuscitation management, trauma mechanism, risk factors, and de novo biomarkers related to prognosis and long-term outcome for evaluating trauma patients besides injury severity score (ISS) guiding the traumatologist. The medicare resource could be utilized efficiently along with increasing in the survival and quality of lifer (QoL) in major trauma.

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
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2015

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

February 1, 2015

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

February 6, 2015

Completed
14 days until next milestone

First Posted

Study publicly available on registry

February 20, 2015

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2020

Completed
Last Updated

March 17, 2015

Status Verified

March 1, 2015

Enrollment Period

4.9 years

First QC Date

February 6, 2015

Last Update Submit

March 9, 2015

Conditions

Wounds and Injuries

Keywords

trauma bluemajor traumacohort studyprognostic factorHealing TimePost Operative

Outcome Measures

Primary Outcomes (1)

  • Event related survival

    since major trauma event till trauma related death

    30 days

Secondary Outcomes (2)

  • Functional status

    12 months

  • over all survival

    2 years

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All major trauma (ISS\>=16 ) patients sent to NTUH and initiated the trauma team, except children younger than 20 years old, pregnancy woman, breast feeding woman, and those forbidden legally.

You may qualify if:

  • age ≧ 20
  • willing to join this study and sign the inform consent form by the patients or their contactable families
  • ISS score ≧ 16, or meet trauma blue or trauma red criteria
  • response to primary resuscitation
  • without uncontrolled or major (\>1500mL) bleeding.

You may not qualify if:

  • active malignancy before the event of major trauma
  • age \<20, pregnancy woman, breast-feeding woman, or mental illness
  • uncontrolled bleeding with hemoglobin \<7g/dL after treatment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, Taiwan, 100, Taiwan

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

CRP, IL-6, cortisol / prolactin / growth hormone

MeSH Terms

Conditions

Wounds and Injuries

Study Officials

  • Ting-Chun Kuo, M.D.

    No.7, Chung San South Road, Taipei City 100, Taiwan (R.O.C.)

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ying-Ru Chen, Master

CONTACT

886972651471ronaldinhol@hotmail.com

Ying-Ru Chen, Master

CONTACT

886972651471

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 6, 2015

First Posted

February 20, 2015

Study Start

February 1, 2015

Primary Completion

January 1, 2020

Study Completion

January 1, 2020

Last Updated

March 17, 2015

Record last verified: 2015-03

Locations

TW(1)