Citation: Shock. 2018 Oct 18.Journal: Shock (Augusta, Ga.).Published: ; 2018ISSN: 1073-2322.Full author list: Shupp JW; Brummel-Ziedins KE; Cohen MJ; Freeman K; Hammamieh R; Mudunuri US; Orfeo T; Moffatt LT; Brownstein BH; Mann KG; Jett M; Pusateri AE.UI/PMID: 30339633.Subject(s): IN PROCESS -- NOT YET INDEXEDInstitution(s): MedStar Health Research Institute | MedStar Washington Hospital CenterDepartment(s): Firefighters' Burn and Surgical Research Laboratory | Surgery/Burn ServicesActivity type: Journal Article.Medline article type(s): Journal ArticleOnline resources: Click here to access onlineDigital Object Identifier: https://dx.doi.org/10.1097/SHK.0000000000001275 (Click here)Abbreviated citation: Shock. 2018 Oct 18.Local Holdings: Available online through MWHC library: 2002 - present.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.Abstract: 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.Abstract: 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.Abstract: 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.This is an open access article distributed under the terms of the Creative Commons Attribution-Non Commercial-No Derivatives License 4.0 (CCBY-NC-ND), where it is permissible to download and share the work provided it is properly cited. The work cannot be changed in any way or used commercially without permission from the journal. http://creativecommons.org/licenses/by-nc-nd/4.0.