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Military Supplement: Assessment of Coagulation Homeostasis in Blunt, Penetrating, and Thermal Trauma: Guidance for a Multi-Center Systems Biology Approach

  1. Author:
    Shupp, Jeffrey W
    Brummel-Ziedins, Kathleen E
    Cohen, Mitchell J
    Freeman, Kalev
    Hammamieh, Rasha
    Mudunuri,Uma
    Orfeo, Thomas
    Moffatt, Lauren T
    Brownstein, Bernard H
    Mann, Kenneth G
    Jett, Marti
    Pusateri, Anthony E
  2. Author Address

    The Burn Center, MedStar Washington Hospital Center., Department of Biochemistry, University of Vermont Larner College of Medicine., Department of Surgery, University of Colorado School of Medicine., Department of Surgery, University of Vermont Larner College of Medicine., Integrative Systems Biology, US Army Medical Research and Materiel Command, USACEHR., Advanced Biomedical and Computational Sciences Group, Frederick National Laboratory for Cancer Research sponsored by the National Cancer Institute., Washington University School of Medicine in St. Louis., Haematologic Technologies Inc., US Army Institute of Surgical Research.,
    1. Year: 2019
    2. Date: Oct
    3. Epub Date: 2018 10 18
  1. Journal: Shock (Augusta, Ga.)
    1. 52
    2. 1S Suppl 1
    3. Pages: 84-91
  2. Type of Article: Article
  3. ISSN: 1073-2322
  1. Abstract:

    Introduction: Provisioning care for traumatically injured patients makes conducting research very proximal to injury difficult. These studies also inherently have regulatory barriers to overcome. Here we outline a protocol for acute-phase enrollment of traumatically injured patients into a prospective observational clinical trial with precise and comprehensive sample acquisition in support of a systems biology approach to a research study. Methods: Experts in trauma, burn, blood coagulation, computational biology, and integrative systems biology developed a prospective study that would capture the natural history of coagulation pathology after traumatic injury. Blood was sampled at admission and serial time points throughout hospitalization. Concurrently, demographic and outcomes data were recorded and on-site point-of-care testing was implemented. Protocols were harmonized across sites and sampling protocols validated through demonstration of feasibility and sample quality assurance testing. A novel data integration platform was developed to store, visualize, and enable large-scale analysis of empirical and clinical data. Regulatory considerations were also addressed in protocol development. Results: A comprehensive Manual of Operations (MOO) was developed and implemented at 3 clinical sites. After regulatory approval, the MOO was followed to collect 5,348 longitudinal samples from 1,547 patients. All samples were collected, processed, and stored per the MOO. Assay results and clinical data were entered into the novel data management platform for analyses. Conclusion: We used an iterative, interdisciplinary process to develop a systematic and robust protocol for comprehensive assessment of coagulation in traumatically injured patients. This MOO can be a template for future studies in the acute setting.

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External Sources

  1. DOI: 10.1097/SHK.0000000000001275
  2. PMID: 30339633
  3. PMCID: PMC6472988
  4. WOS: 000518816600013

Library Notes

  1. Fiscal Year: FY2018-2019
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