ROC Trauma Epistry - Emergency Medicine Research - Ottawa Hospital Research Institute

Overview

The primary aims of the Trauma Epistry study are to: 1. maintain a comprehensive ongoing data infrastructure to facilitate the design, implementation and interpretation of ROC trauma trials; 2. evaluate the ability of prehospital factors to predict in-hospital measures of injury severity in trauma patients with life threatening injury and 3. evaluate the relationships between prehospital injury characteristics, patient characteristics, EMS and regional structure, processes of care, and outcome in trauma patients with life threatening injury.

Duration of Study:

Enrollment began January 2010 – December 2012

For additional information, please contact Cathy Clement, Program Manager.

Protocol Summary

Prospective Observational Prehospital and Hospital Registry for Trauma

Primary Aims
1. To maintain a comprehensive ongoing data infrastructure to facilitate the design, implementation and interpretation of ROC trauma trials. 2. To evaluate the ability of prehospital factors to predict in-hospital measures of injury severity in trauma patients with life threatening injury. 3. To evaluate the relationships between prehospital injury characteristics, patient characteristics, EMS and regional structure, processes of care, and outcome in trauma patients with life threatening injury.

Inclusion Criteria
Systolic blood pressure ≤ 90 mmHg (age adjusted criteria for SBP if age less than 13) or Glasgow Coma Scale score ≤ 8 at any time in the pre-hospital setting and transported to a Level I or II trauma center or died in the field or en route with EMS treatment (e.g. IV, advanced airway).

Exclusion Criteria
Evaluation and declaration of non-survivability without treatment by EMS personnel. Cases of hanging, drowning, primary burn or blunt/penetrating injury with burn injury greater than 20% of the total body surface area.

Study Design
Observational study.

Sample Size
Approximately 1230 Shock patients, 2850 traumatic brain injury patients by June 2010 (including patients from hypertonic saline study), approximately 1660 shock and 3510 TBI patients by June 2012.

Statistical Analysis
Logistic regression (adjusted for site) will be used when outcome is assessed as survival to discharge.

Human Subjects Protection
This study will be carried out under waver of consent due to minimal risk, because study procedure consists only of data collection. Local IRB/REBs will review and approve the protocol.