Recruiting

Observational Study

Sponsor:

National Institute of General Medical Sciences (NIGMS)

Code:

NCT00250523

Conditions

Trauma

Critical Illness

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Study Details

Brief summary:

The purpose of this research study is to gather clinical and biologic information from severely injured patients to better understand and characterize the host response to injury and inflammation across several domains. This information may improve outcome prediction, improve clinical treatment of injured patients, and permit the construction of non-biologic computerized models of illness that can be utilized to represent the host response in future research efforts. This study is designed as the calibration of a mathematical model of this response with predictive capabilities.

The central hypothesis governing this study is that adaptive immune elements are crucial to determining the outcome of complex inflammatory scenarios. We propose to test these hypotheses in the following interrelated Specific Aims:

Specific Aim 1: To develop a robust mathematical model describing trauma/hemorrhage-induced inflammation in humans, its pathologic consequences, and possible therapies.

Specific Aim 2: To translate the mathematical model to humans and create software aimed at individualized clinical decision-making.

Specific Aim 3: To determine the prevalence of an IL-1 receptor-associated kinase (IRAK-1) variant haplotype located on the X-chromosome in an injured population, and to characterize differences in the pro-inflammatory response across gender, relative to the IRAK-1 haplotype.

Specific Aim 4: To determine if increased arginase activity previously observed in isolated peripheral blood mononuclear cells of trauma patients is a consequence of the presence of contaminating activated granulocytes or a particular subset of an arginase positive monocyte subset.

Conditions

Trauma

Critical Illness

Study ID

NCT00250523

Start date

Feb, 2003

Status verified date

Mar, 2021

Completion date

Jul, 2022

Anticipated

Primary completion date

Jul, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Trauma patient cohort inclusion criteria:

  • Present for treatment of their acute, blunt or penetrating injuries to the University of Pittsburgh Medical Center within 6 hours of injury
  • Age greater than or equal to 18 years
  • Intact cervical spinal cord
  • Are admitted to the Intensive Care Unit

Trauma patient cohort exclusion criteria:

  • Anticipated survival < 24 hrs
  • Anticipated survival < 28 days due to pre-existing condition
  • Traumatic Brain injury (GCS ≤8 after ICU admission) AND brain CT abnormality within 12 hr of injury
  • Inability to obtain consent from the subject or their legally authorized representative.
  • Pre-existing immunosuppression
  • Transplant recipient
  • Chronic high doses of steroids (>20 mg prednisone equivalents/day)
  • Significant likelihood of high dose steroids (e.g. spinal cord injury)
  • Oncolytic drug(s) therapy within the past 14 days
  • Known HIV positive status and CD4 count < 200 cells/mm3
  • Admission to the ICU primary for substance withdrawal.
  • Inability to obtain 1st blood sample within 24 hours of injury.

Healthy volunteer cohort inclusion:

  • Age greater than or equal to 18 years
  • Weight > 110 pounds
  • no recent illness or infection in the last two weeks
  • no recent hospitalization or trauma in the last month

Healthy volunteer cohort exclusion:

  • wt < 110 lbs
  • infection or illness in the last two weeks
  • Hospitalization or trauma in the last month

Study Design

Enrollment

520 participants

Anticipated

Interventions and Outcome Measures

Arms

Traumatic injury

ICU Patients with blunt or penetrating injury

2

Healthy volunteers

Primary outcome measure

  • Multiple Organ Failure [ Time Frame: 48 hours ]

Central Contacts and Locations

Central contacts

Stacy D Stull, MS

412-692-4338stullsd@upmc.edu

Locations

University of Pittsburgh Medical Center

Recruiting

Pittsburgh, Pennsylvania, United States, 15213

Principal Investigator:

Jason L Sperry, MD

More Information

Sponsor

National Institute of General Medical Sciences (NIGMS)

Last update posted

Mar 2, 2021

Last verified

Mar, 2021

Keywords

  • trauma
  • critical illness
  • injury

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by National Institute of General Medical Sciences (NIGMS) on 2021-03-02.