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Recruiting

NCT Number: NCT02182180

SC2i Tissue and Data Repository 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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Emory University, Atlanta, Georgia, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Henry M. Jackson Foundation for the Advancement of Military Medicine

Other

Collaborators

  • Duke University
  • Emory University
  • Grady Health System
  • Uniformed Services University of the Health Sciences
  • United States Department of Defense
  • Walter Reed National Military Medical Center

Registry information

Official study title

Surgical Critical Care InitiativeTissue and Data Acquisition Protocol

Acronym: SC2i

Important dates

Study start
2014
Primary completion
2027
Study completion
2027
First posted
Jul 8, 2014
Registry last updated
Sep 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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