NCT02182180 SC2i Tissue and Data Repository Protocol
| NCT ID | NCT02182180 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Henry M. Jackson Foundation for the Advancement of Military Medicine |
| Condition | Critical Illness |
| Study Type | OBSERVATIONAL |
| Enrollment | 5,000 participants |
| Start Date | 2014-09-09 |
| Primary Completion | 2027-08 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 5,000 participants in total. It began in 2014-09-09 with a primary completion date of 2027-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Contact & Investigator
CAPT Eric Elster, MD, US Navy
STUDY DIRECTOR
Uniformed Services University of the Health Sciences
Frequently Asked Questions
Who can join the NCT02182180 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Critical Illness. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT02182180 currently recruiting?
Yes, NCT02182180 is actively recruiting participants. Visit ClinicalTrials.gov or contact Henry M. Jackson Foundation for the Advancement of Military Medicine to inquire about joining.
Where is the NCT02182180 trial being conducted?
This trial is being conducted at Atlanta, United States, Atlanta, United States, Bethesda, United States, Durham, United States.
Who is sponsoring the NCT02182180 clinical trial?
NCT02182180 is sponsored by Henry M. Jackson Foundation for the Advancement of Military Medicine. The principal investigator is CAPT Eric Elster, MD, US Navy at Uniformed Services University of the Health Sciences. The trial plans to enroll 5,000 participants.