SC2i Tissue and Data Repository Protocol (SC2i)

• ClinicalTrials.gov Identifier: NCT02182180
• Recruitment Status: Recruiting
• First Posted: July 8, 2014
• Last Update Posted: September 6, 2019
• 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

• 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
• 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

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
• Listed Location Countries: United States

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