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

Wounds and Injuries Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02367768
• Other study ID #: 201410060RINA
• Status: Recruiting
• Phase: N/A
• First received: February 6, 2015
• Last updated: March 9, 2015
• Start date: February 2015
• Est. completion date: January 2020

Study information

• Verified date: March 2015
• Source: National Taiwan University Hospital
• Contact: Ying-Ru Chen, Master
• Phone: 886972651471
• Email: ronaldinhol[@]hotmail.com
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: January 2020
• Est. primary completion date: January 2020
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Wounds and Injuries

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei City

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Event related survival	since major trauma event till trauma related death	30 days	Yes
Secondary	Functional status	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.	12 months	No
Secondary	over all survival	since major trauma event till death	2 years	Yes