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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

Tracking Information
First Submitted Date June 27, 2014
First Posted Date July 8, 2014
Last Update Posted Date September 6, 2019
Study Start Date November 2014
Estimated Primary Completion Date September 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 7, 2014)
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.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title SC2i Tissue and Data Repository Protocol
Official Title Surgical Critical Care InitiativeTissue and Data Acquisition Protocol
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Critical Illness
Intervention Not Provided
Study Groups/Cohorts Protocol participants
All participants enrolled on the protocol
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: July 7, 2014)
5000
Original Estimated Enrollment Same as current
Estimated Study Completion Date October 2023
Estimated Primary Completion Date September 2023   (Final data collection date for primary outcome measure)
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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT02182180
Other Study ID Numbers SC2I SUR902506
HT94041310032 ( Other Identifier: HJF/USUHS )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Henry M. Jackson Foundation for the Advancement of Military Medicine
Study Sponsor Henry M. Jackson Foundation for the Advancement of Military Medicine
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
Investigators
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
PRS Account Henry M. Jackson Foundation for the Advancement of Military Medicine
Verification Date September 2019