Clinical trial NCT02182180: SC2i Tissue and Data Repository Protocol
Official title: Surgical Critical Care InitiativeTissue and Data Acquisition Protocol
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Critical Illness
Lead sponsor: Henry M. Jackson Foundation for the Advancement of Military Medicine
Sponsor class: OTHER
Collaborators: name: Uniformed Services University of the Health Sciences
name: United States Department of Defense
name: Duke University
name: Emory University
name: Grady Health System
name: Walter Reed National Military Medical Center
First posted: 2014-07-08
Enrollment: 5000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

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.


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.

Primary outcomes:
measure: Collecting, processing and archiving human tissue
timeFrame: Samples will be stored indefinitely in repository
Secondary outcomes:
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Grady Health Systems
state: Georgia
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: Bethesda
country: United States
facility: Walter Reed National Military Medical Center
state: Maryland
city: Durham
country: United States
facility: Duke University Health Systems
state: North Carolina
Study officials:
affiliation: Uniformed Services University of the Health Sciences
name: CAPT Eric Elster, MD, US Navy
role: STUDY_DIRECTOR
affiliation: Duke University
name: Allan M. Kirk, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Emory University
name: Timothy G Buchman, Ph.D, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Grady Hospital
name: Christopher J. Dente, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Uniformed Services University - Walter Reed Surgery
name: Benjamin K Potter, MD, FACS
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.