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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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
Information provided by (Responsible Party):
Henry M. Jackson Foundation for the Advancement of Military Medicine
Tracking Information | ||||||||||||||||
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First Submitted Date | June 27, 2014 | |||||||||||||||
First Posted Date | July 8, 2014 | |||||||||||||||
Last Update Posted Date | August 5, 2021 | |||||||||||||||
Study Start Date | November 2014 | |||||||||||||||
Estimated Primary Completion Date | September 2023 (Final data collection date for primary outcome measure) | |||||||||||||||
Current Primary Outcome Measures |
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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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 |
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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
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Publications * | Gerardo CJ, Silvius E, Schobel S, Eppensteiner JC, McGowan LM, Elster EA, Kirk AD, Limkakeng AT. Association of a Network of Immunologic Response and Clinical Features With the Functional Recovery From Crotalinae Snakebite Envenoming. Front Immunol. 2021 Mar 15;12:628113. doi: 10.3389/fimmu.2021.628113. eCollection 2021. | |||||||||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||||||||||||||
Recruitment Status | Recruiting | |||||||||||||||
Estimated Enrollment |
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:
Exclusion Criteria:
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Sex/Gender |
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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 ) |
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Has Data Monitoring Committee | No | |||||||||||||||
U.S. FDA-regulated Product | Not Provided | |||||||||||||||
IPD Sharing Statement | Not Provided | |||||||||||||||
Current Responsible Party | Henry M. Jackson Foundation for the Advancement of Military Medicine | |||||||||||||||
Original Responsible Party | Same as current | |||||||||||||||
Current Study Sponsor | Henry M. Jackson Foundation for the Advancement of Military Medicine | |||||||||||||||
Original Study Sponsor | Same as current | |||||||||||||||
Collaborators |
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Investigators |
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PRS Account | Henry M. Jackson Foundation for the Advancement of Military Medicine | |||||||||||||||
Verification Date | August 2021 |