Recruiting

Tissue & Data

Sponsor:

Henry M. Jackson Foundation for the Advancement of Military Medicine

Code:

NCT02182180

Conditions

Critical Illness

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Study Details

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.

Conditions

Critical Illness

Study ID

NCT02182180

Start date

Sep 9, 2014

Status verified date

Aug, 2025

Completion date

Aug, 2027

Anticipated

Primary completion date

Aug, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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 Design

Enrollment

5000 participants

Anticipated

Interventions and Outcome Measures

Arms

Protocol participants

All participants enrolled on the protocol

Primary outcome measure

  • Collecting, processing and archiving human tissue [ Time Frame: Samples will be stored indefinitely in repository ]

Central Contacts and Locations

Locations

Grady Health Systems

Recruiting

Atlanta, Georgia, United States, 30303

Contacts

Christopher J. Dente, MD

404-251-8915cdente@emory.edu

Principal Investigator:

Christopher J. Dente, MD

Emory University

Recruiting

Atlanta, Georgia, United States, 30322

Contacts

Timothy Buchman, MD, PhD

404-712-2602tbuchma@emory.edu

Principal Investigator:

Timothy G Buchman, Ph.D., MD

Walter Reed National Military Medical Center

Recruiting

Bethesda, Maryland, United States, 20889

Contacts

Benjamin K Potter, MD, FACS

301-400-2723benjamin.k.potter.mil@mail.mil

Principal Investigator:

Benjamin K Potter, MD, FACS

Duke University Health Systems

Recruiting

Durham, North Carolina, United States, 27710

Contacts

Allan Kirk, MD, PhD

919-681-4853allan.kirk@dm.duke.edu

Principal Investigator:

Allan Krik, MD, Ph.D

More Information

Sponsor

Henry M. Jackson Foundation for the Advancement of Military Medicine

Last update posted

Sep 4, 2025

Last verified

Aug, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Henry M. Jackson Foundation for the Advancement of Military Medicine on 2025-09-04.