TraumaNCT00250523
Mathematical Modeling of the Acute Inflammatory Response Following Injury
An observational study of Trauma and Critical Illness, run by National Institute of General Medical Sciences (NIGMS) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Trauma, Critical Illness
- How many people
- 520 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2003to Jul 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Subjects to be recruited will consist of trauma patients and healthy volunteers:
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
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
Jason L Sperry, MD
About this study
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:
Read more
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
- Keywords
- trauma, critical illness, injury
- Medical subject headings
- Wounds and Injuries, Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Traumatic injury | ICU Patients with blunt or penetrating injury | |
| 2 | Healthy volunteers |
What is being measured
The primary outcome is the main question the study is designed to answer.
Multiple Organ Failure
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2005 (estimated)
- Study startFeb 2003
- Primary completionJul 2022 (estimated)
- Study completionJul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TraumaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 520 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Institute of General Medical Sciences (NIGMS)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Principal investigator, Dr Jason L Sperry, National Institute of General Medical Sciences (NIGMS)
- Investigators
- Jason L Sperry, MD, Principal investigator, UPMC Department of Surgery/Critical Care Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00250523
- Sponsor's protocol ID
- PRO 0801232
- Other IDs
- P50GM053789-09
- Status last verified
- Mar 2021
- First submitted
- 7 Nov 2005
- Last updated
- 2 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mathematical Modeling of the Acute Inflammatory Response Following Injury
- ClinicalTrials.gov ID
- NCT00250523
- Acronym / sponsor ID
- PRO 0801232
- Conditions
- Trauma, Critical Illness
- Keywords
- trauma, critical illness, injury
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 520 participants (estimated)
- Lead sponsor
- National Institute of General Medical Sciences (NIGMS)US National Institutes of Health
- Study start
- Feb 2003
- Primary completion
- Jul 2022 (estimated)
- Study completion
- Jul 2022 (estimated)
- First posted
- 8 Nov 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Traumatic injury | – | –ICU Patients with blunt or penetrating injury |
| 2 | – | –Healthy volunteers |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects to be recruited will consist of trauma patients and healthy volunteers:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Multiple Organ Failure
Time frame: 48 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jason L Sperry, MD principal investigator
UPMC Department of Surgery/Critical Care Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Trauma and Critical Illness, run by National Institute of General Medical Sciences (NIGMS) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Stacy D Stull, MS (412-692-4338, stullsd@upmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Multiple Organ Failure (time frame: 48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2021; AzTrials last refreshed its copy on 8 Nov 2026.