SC2i Tissue and Data Repository Protocol (SC2i)

Surgical Critical Care InitiativeTissue and Data Acquisition Protocol

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.

Study Overview

• Status: Recruiting
• Conditions: Critical Illness

• Study Type: Observational
• Enrollment (Anticipated): 5000

Contacts and Locations

Study Locations

• United States
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Recruiting
      • Emory University
      • Contact: Timothy Buchman, MD, PhD; Phone Number: 404-712-2602; Email: tbuchma@emory.edu
      • Principal Investigator: Timothy G Buchman, Ph.D., MD
    • Atlanta, Georgia, United States, 30303
      • Recruiting
      • Grady Health Systems
      • Contact: Christopher J. Dente, MD; Phone Number: 404-251-8915; Email: cdente@emory.edu
      • Principal Investigator: Christopher J. Dente, MD
  • Maryland
    • Bethesda, Maryland, United States, 20889
      • Recruiting
      • Walter Reed National Military Medical Center
      • Contact: Benjamin K Potter, MD, FACS; Phone Number: 301-400-2723; Email: benjamin.k.potter.mil@mail.mil
      • Principal Investigator: Benjamin K Potter, MD, FACS
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Recruiting
      • Duke University Health Systems
      • Contact: Allan Kirk, MD, PhD; Phone Number: 919-681-4853; Email: allan.kirk@dm.duke.edu
      • Principal Investigator: Allan Krik, MD, Ph.D

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Protocol participants; All participants enrolled on the protocol

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Collecting, processing and archiving human tissue	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.	Samples will be stored indefinitely in repository

Collaborators and Investigators

• Sponsor: Henry M. Jackson Foundation for the Advancement of Military Medicine
• Collaborators: United States Department of Defense; Emory University; Duke University; Walter Reed National Military Medical Center; Uniformed Services University of the Health Sciences; Grady Health System
• 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

Publications and helpful links

General 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.

Helpful Links

• Henry M. Jackson Foundation for the Advancement of Military Medicine, Inc.
• Uniformed Services University of the Health Sciences
• Grady Health Systems
• Duke University Medical Center
• Emory Healthcare

Study record dates

Study Major Dates

• Study Start: November 1, 2014
• Primary Completion (Anticipated): September 1, 2023
• Study Completion (Anticipated): October 1, 2023

Study Registration Dates

• First Submitted: June 27, 2014
• First Submitted That Met QC Criteria: July 7, 2014
• First Posted (Estimate): July 8, 2014

Study Record Updates

• Last Update Posted (Actual): August 5, 2021
• Last Update Submitted That Met QC Criteria: August 3, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Critical Illness
• Other Study ID Numbers: SC2I SUR902506; HT94041310032 (Other Identifier: HJF/USUHS)