SC2i Tissue and Data Repository Protocol

Critical Illness Clinical Trial

— SC2i  

Official title:

Surgical Critical Care InitiativeTissue and Data Acquisition Protocol

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02182180
• Other study ID #: SC2I SUR902506
• Secondary ID: HT94041310032
• Status: Recruiting
• Start date: November 2014
• Est. completion date: October 2023

Study information

• Verified date: August 2021
• Source: Henry M. Jackson Foundation for the Advancement of Military Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 5000
• Est. completion date: October 2023
• Est. primary completion date: September 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Critical Illness

Locations

Country	Name	City	State
United States	Emory University	Atlanta	Georgia
United States	Grady Health Systems	Atlanta	Georgia
United States	Walter Reed National Military Medical Center	Bethesda	Maryland
United States	Duke University Health Systems	Durham	North Carolina

Sponsors (7)

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

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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

External Links

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