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Long-term Outcome Related Prognostic Factor and Biomarkers of Major Trauma Database Analysis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02367768
Recruitment Status : Recruiting
First Posted : February 20, 2015
Last Update Posted : March 17, 2015
Information provided by (Responsible Party):
National Taiwan University Hospital

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.

Condition or disease
Wounds and Injuries

Detailed Description:

Severe traumatic injury occupied the sixth leading cause of death in Taiwan, especially in young adults. In 2013, there were accidental deaths in every 76 minutes. Not compared with the malignancy, heart disease, cerebrovascular disease, diabetes mellitus, or pneumonia Since 1995, Taiwan replaced a previous patchwork of separate social health insurance funds with one single-payer, National Health Insurance (NHI) scheme that is administered by an agency of the central government's Department of Health. NHI supported the cost of Critical Illness and Injury that numerous patients with major trauma were eligible for preference. However, the national medical cost of trauma care, especially in poly-trauma or major trauma were impressive: the adjusted national inpatient trauma yearly costs were estimated at $37,511,328,659 US dollars; the national insurance cost provided by Bureau of National Health Insurance, Department of Health for trauma was over $20,000,000,000 new Taiwan dollars till 1999 with increasing yearly.

Recently it flashed bulletins nationwide and overseas for catastrophes, such as aircraft accident, wrecks, or underground gas explosions. There was a stirring of interest in life support system for major trauma related rescue from dying. Death to trauma is caused by costly damages on scene, hemorrhage shock or trauma and massive transfusion related acute respiratory distress syndrome (ARDS). Extra-Corporeal Membrane Oxygenation (ECMO) can rescue life from severe cardiopulmonary failure, but coexisting complication as bleeding and coagulopathy restricting the utilization the use in trauma patients. Besides, there were more portable ECMO sets making a debut, especially for air transportation. It act now the medical transferral for trauma patients under ECMO support. The portable ECMO sets launched with possibility, accessibility, and convenience. The issue of life support system utilization, long-term outcome, and medical cost-effectiveness for major trauma patients was worth discussing no matter in National Taiwan University Hospital (NTUH) trauma database or National Health Insurance Research Database (NHIRD).

Immune system alteration was previously considered the mechanism of post-traumatic stress disorder (PTSD). Moreover, an externally experienced traumatic event induces downstream alterations in immune function by reducing methylation.

Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Long-term Outcome Related Prognostic Factor and Biomarkers of Major Trauma Database Analysis
Study Start Date : February 2015
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : January 2020

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Event related survival [ Time Frame: 30 days ]
    since major trauma event till trauma related death

Secondary Outcome Measures :
  1. Functional status [ Time Frame: 12 months ]
    Besides Rehabilitation Complexity Scale (RCS) and Functional Independence Measure (FIM) for traumatic brain injury patients, Glasgow Outcome Scale - Extended (GOS-E) and European Quality of Life Five Dimensions Questionnaire (EQ-5D) are used in concerning longer-term outcome indicators. There are currently no robust measures of patient experience for use in major trauma. Functional status after the major trauma event could be measured using non-clinical outcomes such as return to work, maintenance of education and societal dependency at post injury 3, 6, and 12 months.

  2. over all survival [ Time Frame: 2 years ]
    since major trauma event till death

Biospecimen Retention:   Samples Without DNA
CRP, IL-6, cortisol / prolactin / growth hormone

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-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.

Inclusion criteria:

  • 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.

Exclusion criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02367768

Contact: Ying-Ru Chen, Master 886972651471
Contact: Ying-Ru Chen, Master 886972651471

National Taiwan University Hospital Recruiting
Taipei City, Taiwan, 100
Contact: Ting-Chun Kuo    886-97265-3245   
Sponsors and Collaborators
National Taiwan University Hospital
Principal Investigator: Ting-Chun Kuo, M.D. No.7, Chung San South Road, Taipei City 100, Taiwan (R.O.C.)

Responsible Party: National Taiwan University Hospital Identifier: NCT02367768     History of Changes
Other Study ID Numbers: 201410060RINA
First Posted: February 20, 2015    Key Record Dates
Last Update Posted: March 17, 2015
Last Verified: March 2015

Keywords provided by National Taiwan University Hospital:
trauma blue
major trauma
cohort study
prognostic factor
Healing Time
Post Operative

Additional relevant MeSH terms:
Wounds and Injuries