Critical IllnessSC2iNCT02182180
SC2i Tissue and Data Repository Protocol
An observational study of Critical Illness, run by Henry M. Jackson Foundation for the Advancement of Military Medicine at 4 sites in United States.
Trial summary
The purpose of this study is to collect samples of blood, urine, cerebrospinal fluid (CSF, the fluid that surrounds the brain and spinal cord), wound tissue and/or wound fluids, and other body fluids and tissues from people who have been seriously injured or ill. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Critical Illness
- How many people
- 5,000 participants
- Where
- 4 sitesUnited States
- Study dates
- 9 Sep 2014to Aug 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: Patients with injury or illness requiring surgical care or treatment in a critical care or emergency setting who are being cared for at SC2I sites, including Grady Memorial Hospital, Emory University Hospital, and Duke University Health System. Also, healthy volunteer control subjects to include individuals without any known injury or end-stage organ disease and patients who have recovered from prior injury.
Who may be able to join
- Patients with injury or illness requiring surgical care or treatment in a critical care or emergency setting who are being cared for at SC2I sites (Grady Memorial Hospital, Emory Univeristy Hospital, and Duke University Health Systems)
- Healthy volunteer control subjects to include individuals without any known injury or end-stage organ disease and patients who have recovered from prior injury.
- Ability to understand the purposes and risks of the study and willingly give written informed consent, or in the case of incapacitated patients, a willing surrogate able to give written informed consent.
Who cannot join
- Any condition that, in the opinion of the attending physician, would place the patient or volunteer subject at undue risk by participating. Specific conditions include but are not limited to anemia prohibitive of phlebotomy, coagulopathy, or technical considerations that would prevent acquisition of sufficient tissue or fluid for clinical use. Acquisition of samples from patients requiring active transfusion or with transfusion-associated coagulopathy will be considered as appropriate study candidates at the discretion of the attending physician.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States4 sites, 4 recruiting
- Recruiting
Grady Health Systems
Atlanta, Georgia, 30303
Christopher J. Dente, MD, 404-251-8915, cdente@emory.edu
Christopher J. Dente, MD
- Recruiting
Emory University
Atlanta, Georgia, 30322
Timothy Buchman, MD, PhD, 404-712-2602, tbuchma@emory.edu
Timothy G Buchman, Ph.D., MD
- Recruiting
Walter Reed National Military Medical Center
Bethesda, Maryland, 20889
Benjamin K Potter, MD, FACS, 301-400-2723, benjamin.k.potter.mil@mail.mil
Benjamin K Potter, MD, FACS
- Recruiting
Duke University Health Systems
Durham, North Carolina, 27710
Allan Kirk, MD, PhD, 919-681-4853, allan.kirk@dm.duke.edu
Allan Krik, MD, Ph.D
About this study
Official title: Surgical Critical Care InitiativeTissue and Data Acquisition Protocol
The purpose of this study is to collect samples of blood, urine, cerebrospinal fluid (CSF, the fluid that surrounds the brain and spinal cord), wound tissue and/or wound fluids, and other body fluids and tissues from people who have been seriously injured or ill. The samples will be used to develop and assess tests and/or tools that doctors can use to decide the best treatment plan for seriously injured or ill military personnel and for civilians. Additonal protocols to use the samples will be submitted as separate protocols.
- Conditions
- Critical Illness
- Medical subject headings
- 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 |
|---|---|---|
| Protocol participants | All participants enrolled on the protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Collecting, processing and archiving human tissue
Samples of blood, urine, cerebrospinal fluid, wound tissue and/or wound fluids, and other body fluids and tissues from people who have been seriously injured or ill will be collected. The samples will be used to develop and assess tests and/or tools that doctors can use to decide the best treatment plan for seriously injured or ill military personnel and for civilians. Additional research on the samples will be under separate protocols. This is a collection protocol.
Measured: Samples will be stored indefinitely in repository
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2014 (estimated)
- Study start9 Sep 2014
- Primary completionAug 2027 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Critical IllnessStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 5,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Henry M. Jackson Foundation for the Advancement of Military Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Uniformed Services University of the Health Sciences, United States Department of Defense, Duke University, Emory University, Grady Health System, Walter Reed National Military Medical Center
- Responsible party
- Sponsor
- Investigators
- CAPT Eric Elster, MD, US Navy, Study director, Uniformed Services University of the Health SciencesAllan M. Kirk, MD, PhD, Principal investigator, Duke UniversityTimothy G Buchman, Ph.D, MD, Principal investigator, Emory UniversityChristopher J. Dente, MD, Principal investigator, Grady HospitalBenjamin K Potter, MD, FACS, Principal investigator, Uniformed Services University - Walter Reed Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02182180
- Sponsor's protocol ID
- SC2I SUR902506
- Other IDs
- HT94041310032
- Acronym
- SC2i
- Status last verified
- Aug 2025
- First submitted
- 27 Jun 2014
- Last updated
- 4 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
Publications
Haines KL, Li R, Grey S, Kim HE, Gann E, Almond C, Rouse M, Joshi M, Schobel S, Agarwal S, Kirk A, Elster E, Fernandez-Moure JS. Exploratory cluster analysis of IL2Ra and associated biomarkers and complications after blunt chest trauma. J Trauma Acute Care Surg. 2025 Jun 1;98(6):899-906. doi: 10.1097/TA.0000000000004568. Epub 2025 Apr 14.
PubMed 40223169Rindler RS, Robertson H, De Yampert L, Khatri V, Texakalidis P, Eshraghi S, Grey S, Schobel S, Elster EA, Boulis N, Grossberg JA. Predicting Vasospasm and Early Mortality in Severe Traumatic Brain Injury: A Model Using Serum Cytokines, Neuronal Proteins, and Clinical Data. Neurosurgery. 2025 May 1;96(5):1133-1145. doi: 10.1227/neu.0000000000003224. Epub 2024 Oct 11.
PubMed 39471078Gerardo CJ, Silvius E, Schobel S, Eppensteiner JC, McGowan LM, Elster EA, Kirk AD, Limkakeng AT. Association of a Network of Immunologic Response and Clinical Features With the Functional Recovery From Crotalinae Snakebite Envenoming. Front Immunol. 2021 Mar 15;12:628113. doi: 10.3389/fimmu.2021.628113. eCollection 2021.
PubMed 33790901
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surgical Critical Care InitiativeTissue and Data Acquisition Protocol
- ClinicalTrials.gov ID
- NCT02182180
- Acronym / sponsor ID
- SC2i / SC2I SUR902506
- Conditions
- Critical Illness
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- Henry M. Jackson Foundation for the Advancement of Military MedicineUniversity, hospital or other
- Collaborators
- Uniformed Services University of the Health Sciences, United States Department of Defense, Duke University, Emory University, Grady Health System, Walter Reed National Military Medical Center
- Study start
- 9 Sep 2014 (actual)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 8 Jul 2014 (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 study is to collect samples of blood, urine, cerebrospinal fluid (CSF, the fluid that surrounds the brain and spinal cord), wound tissue and/or wound fluids, and other body fluids and tissues from people who have been seriously injured or ill. The samples will be used to develop and assess tests and/or tools that doctors can use to decide the best treatment plan for seriously injured or ill military personnel and for civilians. Additonal protocols to use the samples will be submitted as separate protocols.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Protocol participants | – | –All participants enrolled on the protocol |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with injury or illness requiring surgical care or treatment in a critical care or emergency setting who are being cared for at SC2I sites, including Grady Memorial Hospital, Emory University Hospital, and Duke University Health System. Also, healthy volunteer control subjects to include individuals without any known injury or end-stage organ disease and patients who have recovered from prior injury.
Key inclusion criteria (3 listed)
- Patients with injury or illness requiring surgical care or treatment in a critical care or emergency setting who are being cared for at SC2I sites (Grady Memorial Hospital, Emory Univeristy Hospital, and Duke University Health Systems)
- Healthy volunteer control subjects to include individuals without any known injury or end-stage organ disease and patients who have recovered from prior injury.
- Ability to understand the purposes and risks of the study and willingly give written informed consent, or in the case of incapacitated patients, a willing surrogate able to give written informed consent.
Key exclusion criteria (1 listed)
- Any condition that, in the opinion of the attending physician, would place the patient or volunteer subject at undue risk by participating. Specific conditions include but are not limited to anemia prohibitive of phlebotomy, coagulopathy, or technical considerations that would prevent acquisition of sufficient tissue or fluid for clinical use. Acquisition of samples from patients requiring active transfusion or with transfusion-associated coagulopathy will be considered as appropriate study candidates at the discretion of the attending physician.
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
Collecting, processing and archiving human tissue
Time frame: Samples will be stored indefinitely in repository
Samples of blood, urine, cerebrospinal fluid, wound tissue and/or wound fluids, and other body fluids and tissues from people who have been seriously injured or ill will be collected. The samples will be used to develop and assess tests and/or tools that doctors can use to decide the best treatment plan for seriously injured or ill military personnel and for civilians. Additional research on the samples will be under separate protocols. This is a collection protocol.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2025.
- Derived from this study: PubMed 40223169Haines KL, Li R, Grey S, Kim HE, Gann E, Almond C, Rouse M, Joshi M, Schobel S, Agarwal S, Kirk A, Elster E, Fernandez-Moure JS. Exploratory cluster analysis of IL2Ra and associated biomarkers and complications after blunt chest trauma. J Trauma Acute Care Surg. 2025 Jun 1;98(6):899-906. doi: 10.1097/TA.0000000000004568. Epub 2025 Apr 14.
- Derived from this study: PubMed 39471078Rindler RS, Robertson H, De Yampert L, Khatri V, Texakalidis P, Eshraghi S, Grey S, Schobel S, Elster EA, Boulis N, Grossberg JA. Predicting Vasospasm and Early Mortality in Severe Traumatic Brain Injury: A Model Using Serum Cytokines, Neuronal Proteins, and Clinical Data. Neurosurgery. 2025 May 1;96(5):1133-1145. doi: 10.1227/neu.0000000000003224. Epub 2024 Oct 11.
- Derived from this study: PubMed 33790901Gerardo CJ, Silvius E, Schobel S, Eppensteiner JC, McGowan LM, Elster EA, Kirk AD, Limkakeng AT. Association of a Network of Immunologic Response and Clinical Features With the Functional Recovery From Crotalinae Snakebite Envenoming. Front Immunol. 2021 Mar 15;12:628113. doi: 10.3389/fimmu.2021.628113. eCollection 2021.
- Henry M. Jackson Foundation for the Advancement of Military Medicine, Inc.Link provided by the sponsor.
- Uniformed Services University of the Health SciencesLink provided by the sponsor.
- Grady Health SystemsLink provided by the sponsor.
- Duke University Medical CenterLink provided by the sponsor.
- Emory HealthcareLink provided by the sponsor.
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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.
Walter Reed National Military Medical Center
Bethesda, United States
CAPT Eric Elster, MD, US Navy study director
Uniformed Services University of the Health Sciences
Allan M. Kirk, MD, PhD principal investigator
Duke University
Timothy G Buchman, Ph.D, MD principal investigator
Emory University
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Critical Illness, run by Henry M. Jackson Foundation for the Advancement of Military Medicine at 4 sites 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?
The sponsor lists 3 inclusion and 1 exclusion criteria. 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: looking for participants now, as of the sponsor's last update on 4 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Collecting, processing and archiving human tissue (time frame: Samples will be stored indefinitely in repository). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02182180, which also lists 3 linked publications.
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 4 Sep 2025.