SC2i Tissue and Data Repository Protocol

NCT02182180 | Recruiting

• 2 other identifiers: SC2I SUR902506HT94041310032
• Study Type: observational
• Target: 5,000
• Locations: 1 country
• Sites: 4

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

Outcome Measures

Primary Outcomes (1)

• 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.

  Samples will be stored indefinitely in repository

Study Arms (1)

Protocol participants

All participants enrolled on the protocol

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Henry M. Jackson Foundation for the Advancement of Military Medicine: lead
• Uniformed Services University of the Health Sciences: collaborator
• United States Department of Defense: collaborator
• Duke University: collaborator
• Emory University: collaborator
• Grady Health System: collaborator
• Walter Reed National Military Medical Center: collaborator

Study Sites (4)

Grady Health Systems

Atlanta, Georgia, 30303, United States

RECRUITING

Emory University

Atlanta, Georgia, 30322, United States

RECRUITING

Walter Reed National Military Medical Center

Bethesda, Maryland, 20889, United States

RECRUITING

Duke University Health Systems

Durham, North Carolina, 27710, United States

RECRUITING

Related Publications (3)

• 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.

  PMID: 40223169 DERIVED

• 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.

  PMID: 39471078 DERIVED

• 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.

  PMID: 33790901 DERIVED

Related Links

• Henry M. Jackson Foundation for the Advancement of Military Medicine, Inc.
• Uniformed Services University of the Health Sciences
• Grady Health Systems
• Duke University Medical Center
• Emory Healthcare

MeSH Terms

Conditions

Critical Illness

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• CAPT Eric Elster, MD, US Navy

  Uniformed Services University of the Health Sciences

  STUDY DIRECTOR

• Allan M. Kirk, MD, PhD

  Duke University

  PRINCIPAL INVESTIGATOR

• Timothy G Buchman, Ph.D, MD

  Emory University

  PRINCIPAL INVESTIGATOR

• Christopher J. Dente, MD

  Grady Hospital

  PRINCIPAL INVESTIGATOR

• Benjamin K Potter, MD, FACS

  Uniformed Services University - Walter Reed Surgery

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 27, 2014
• First Posted: July 8, 2014
• Study Start: September 9, 2014
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: September 4, 2025

Record last verified: 2025-08

Locations

US (4)