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SC2i Tissue and Data Repository Protocol (SC2i)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02182180
Recruitment Status : Recruiting
First Posted : July 8, 2014
Last Update Posted : September 6, 2019
Sponsor:
Collaborators:
Uniformed Services University of the Health Sciences
United States Department of Defense
Duke University
Emory University
Grady Health System
Walter Reed National Military Medical Center
Information provided by (Responsible Party):
Henry M. Jackson Foundation for the Advancement of Military Medicine

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.

Condition or disease
Critical Illness

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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
Protocol participants
All participants enrolled on the protocol



Primary Outcome Measures :
  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.



Information from the National Library of Medicine

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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
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.
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.

Information from the National Library of Medicine

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


Locations
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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         
Sponsors and Collaborators
Henry M. Jackson Foundation for the Advancement of Military Medicine
Uniformed Services University of the Health Sciences
United States Department of Defense
Duke University
Emory University
Grady Health System
Walter Reed National Military Medical Center
Investigators
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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

Additional Information:
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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: September 6, 2019
Last Verified: September 2019
Additional relevant MeSH terms:
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Critical Illness
Disease Attributes
Pathologic Processes