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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02367768
Enrollment
500
Registered
2015-02-20
Start date
2015-02-28
Completion date
2020-01-31
Last updated
2015-03-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Wounds and Injuries

Keywords

trauma blue, major trauma, cohort study, prognostic factor, Healing Time, Post Operative

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.

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.

Interventions

None listed

Sponsors

National Taiwan University Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Event related survival30 dayssince major trauma event till trauma related death

Secondary

MeasureTime frameDescription
Functional status12 monthsBesides 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.
over all survival2 yearssince major trauma event till death

Countries

Taiwan

Contacts

Primary ContactYing-Ru Chen, Master
ronaldinhol@hotmail.com886972651471
Backup ContactYing-Ru Chen, Master
886972651471

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026