SC2i Tissue and Data Repository Protocol

NCT ID: NCT02182180

Last Updated: 2025-09-04

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 5000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-09-09
• Study Completion Date: 2027-08-31

Brief 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. 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

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Protocol participants

All participants enrolled on the protocol

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Uniformed Services University of the Health Sciences

FED

Sponsor Role: collaborator

United States Department of Defense

FED

Sponsor Role: collaborator

Duke University

OTHER

Sponsor Role: collaborator

Emory University

OTHER

Sponsor Role: collaborator

Grady Health System

OTHER

Sponsor Role: collaborator

Walter Reed National Military Medical Center

FED

Sponsor Role: collaborator

Henry M. Jackson Foundation for the Advancement of Military Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

CAPT Eric Elster, MD, US Navy

Role: STUDY_DIRECTOR

Uniformed Services University of the Health Sciences

Allan M. Kirk, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Duke University

Timothy G Buchman, Ph.D, MD

Role: PRINCIPAL_INVESTIGATOR

Emory University

Christopher J. Dente, MD

Role: PRINCIPAL_INVESTIGATOR

Grady Hospital

Benjamin K Potter, MD, FACS

Role: PRINCIPAL_INVESTIGATOR

Uniformed Services University - Walter Reed Surgery

Locations

Grady Health Systems

Atlanta, Georgia, United States

Site Status: RECRUITING

Emory University

Atlanta, Georgia, United States

Site Status: RECRUITING

Walter Reed National Military Medical Center

Bethesda, Maryland, United States

Site Status: RECRUITING

Duke University Health Systems

Durham, North Carolina, United States

Site Status: RECRUITING

Countries

United States

Facility Contacts

Christopher J. Dente, MD

Role: primary

cdente@emory.edu

404-251-8915

Timothy Buchman, MD, PhD

Role: primary

tbuchma@emory.edu

404-712-2602

Benjamin K Potter, MD, FACS

Role: primary

benjamin.k.potter.mil@mail.mil

301-400-2723

Allan Kirk, MD, PhD

Role: primary

allan.kirk@dm.duke.edu

919-681-4853

References

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.

Reference Type: DERIVED

PMID: 40223169 (View on PubMed)

Rindler 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. 2024 Oct 11. doi: 10.1227/neu.0000000000003224. Online ahead of print.

Reference Type: DERIVED

PMID: 39471078 (View on PubMed)

Gerardo 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.

Reference Type: DERIVED

PMID: 33790901 (View on PubMed)

Related Links

http://www.hjf.org

Henry M. Jackson Foundation for the Advancement of Military Medicine, Inc.

http://www.usuhs.edu

Uniformed Services University of the Health Sciences

http://www.gradyhealth.org/

Grady Health Systems

http://www.dukemedicine.org/

Duke University Medical Center

http://www.emoryhealthcare.org

Emory Healthcare

Other Identifiers

HT94041310032

Identifier Type: OTHER

Identifier Source: secondary_id

SC2I SUR902506

Identifier Type: -

Identifier Source: org_study_id