SC2i Tissue and Data Repository Protocol (SC2i)
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ClinicalTrials.gov Identifier: NCT02182180 |
Recruitment Status :
Recruiting
First Posted : July 8, 2014
Last Update Posted : August 5, 2021
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Condition or disease |
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Critical Illness |
Study Type : | Observational |
Estimated Enrollment : | 5000 participants |
Observational Model: | Case-Control |
Time Perspective: | Prospective |
Official Title: | Surgical Critical Care InitiativeTissue and Data Acquisition Protocol |
Study Start Date : | November 2014 |
Estimated Primary Completion Date : | September 2023 |
Estimated Study Completion Date : | October 2023 |
Group/Cohort |
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Protocol participants
All participants enrolled on the protocol
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- 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.

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02182180
United States, Georgia | |
Grady Health Systems | Recruiting |
Atlanta, Georgia, United States, 30303 | |
Contact: Christopher J. Dente, MD 404-251-8915 cdente@emory.edu | |
Principal Investigator: Christopher J. Dente, MD | |
Emory University | Recruiting |
Atlanta, Georgia, United States, 30322 | |
Contact: Timothy Buchman, MD, PhD 404-712-2602 tbuchma@emory.edu | |
Principal Investigator: Timothy G Buchman, Ph.D., MD | |
United States, Maryland | |
Walter Reed National Military Medical Center | Recruiting |
Bethesda, Maryland, United States, 20889 | |
Contact: Benjamin K Potter, MD, FACS 301-400-2723 benjamin.k.potter.mil@mail.mil | |
Principal Investigator: Benjamin K Potter, MD, FACS | |
United States, North Carolina | |
Duke University Health Systems | Recruiting |
Durham, North Carolina, United States, 27710 | |
Contact: Allan Kirk, MD, PhD 919-681-4853 allan.kirk@dm.duke.edu | |
Principal Investigator: Allan Krik, MD, Ph.D |
Study Director: | CAPT Eric Elster, MD, US Navy | Uniformed Services University of the Health Sciences | |
Principal Investigator: | 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 |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Henry M. Jackson Foundation for the Advancement of Military Medicine |
ClinicalTrials.gov Identifier: | NCT02182180 |
Other Study ID Numbers: |
SC2I SUR902506 HT94041310032 ( Other Identifier: HJF/USUHS ) |
First Posted: | July 8, 2014 Key Record Dates |
Last Update Posted: | August 5, 2021 |
Last Verified: | August 2021 |
Critical Illness Disease Attributes Pathologic Processes |