RECRUITING

SC2i Tissue and Data Repository Protocol

Description

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

Study Details

Study overview

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.

Surgical Critical Care InitiativeTissue and Data Acquisition Protocol

SC2i Tissue and Data Repository Protocol

Condition
Critical Illness
Intervention / Treatment

-

Contacts and Locations

Atlanta

Grady Health Systems, Atlanta, Georgia, United States, 30303

Atlanta

Emory University, Atlanta, Georgia, United States, 30322

Bethesda

Walter Reed National Military Medical Center, Bethesda, Maryland, United States, 20889

Durham

Duke University Health Systems, Durham, North Carolina, United States, 27710

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

Henry M. Jackson Foundation for the Advancement of Military Medicine,

CAPT Eric Elster, MD, US Navy, STUDY_DIRECTOR, Uniformed Services University of the Health Sciences

Allan M. Kirk, MD, PhD, PRINCIPAL_INVESTIGATOR, Duke University

Timothy G Buchman, Ph.D, MD, PRINCIPAL_INVESTIGATOR, Emory University

Christopher J. Dente, MD, PRINCIPAL_INVESTIGATOR, Grady Hospital

Benjamin K Potter, MD, FACS, PRINCIPAL_INVESTIGATOR, Uniformed Services University - Walter Reed Surgery

Study Record Dates

2027-08