SC2i Tissue and Data Repository for Critical Illness

Surgical Critical Care InitiativeTissue and Data Acquisition Protocol

This project collects blood, urine, CSF, wound and other tissue samples from people with serious injuries or critical illness so researchers can try to develop tests and tools to guide treatment for military members and civilians.

Quick facts

• Study type: Observational
• Enrollment: 5000 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Henry M. Jackson Foundation for the Advancement of Military Medicine (Academic / other)
• Locations: 4 sites (Atlanta, Georgia and 3 other locations)
• Trial ID: NCT02182180 on ClinicalTrials.gov

What this trial studies

This is an observational biorepository that prospectively collects blood, urine, cerebrospinal fluid, wound tissue/fluids, and other biological samples from critically ill or seriously injured patients at participating SC2i sites. Healthy volunteers and recovered patients are also enrolled as control subjects. Samples are stored and made available under separate protocols to support development of diagnostic and prognostic tests and clinical decision tools. Consent is obtained from participants or authorized surrogates, and procedures exclude patients for whom sampling would pose undue clinical risk.

Who should consider this trial

Good fit: Ideal candidates are people who are seriously injured or critically ill and receiving care at participating SC2i sites, plus healthy volunteers or recovered patients who can provide consent or have an authorized surrogate.

Not a fit: Patients who are not treated at participating sites, who have conditions that make sampling unsafe (for example severe anemia or coagulopathy), or who lack consent and a surrogate likely will not benefit from participation.

Why it matters

Potential benefit: If successful, tests and tools developed from these samples could help clinicians choose better, timelier treatments and improve outcomes for people with severe injuries or critical illness.

How similar studies have performed: Biorepositories and specimen banks have previously enabled development of diagnostics and biomarkers in critical illness and trauma, though this SC2i repository is primarily an infrastructure effort to support future testing.

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.

Where this trial is running

Atlanta, Georgia and 3 other locations

• Grady Health Systems — Atlanta, Georgia, United States (Recruiting)
• Emory University — Atlanta, Georgia, United States (Recruiting)
• Walter Reed National Military Medical Center — Bethesda, Maryland, United States (Recruiting)
• Duke University Health Systems — Durham, North Carolina, United States (Recruiting)

Study contacts

• Principal investigator: Allan M. Kirk, MD, PhD — Duke University

Conditions Critical Illness