Trauma Induced Coagulopathy and Inflammation

Completed

• Conditions: Trauma Injury; Trauma; Coagulopathy
• Interventions: Diagnostic Test: Thromboelastography; Diagnostic Test: Computational model

• Registration Number: NCT03128658
• Lead Sponsor: University of Pennsylvania

Brief Summary

While a number of factors are known to be associated with the development of trauma induced coagulopathy (TIC), inflammation, and multi-organ failure, we currently cannot predict which patients are at risk for developing these life threatening conditions with any certainty. In this prospective observational study, we will investigate the many factors that contribute to the development of trauma induced coagulopathy, post injury inflammation and the development of organ dysfunction in order to develop a multi scale computational algorithm of clinical prediction. Using a convenience sample technique, demographic data, physiologic data, blood samples and clinical variables will be collected over 5 days following traumatic injury. A computational model will be used to predict the development of TIC and multi-organ failure.

Detailed Description

A prospective, observational, convenience sample of trauma patients 18 years old or older who present to the trauma bay as a trauma alert will be included after evaluation by the on-call trauma surgeon and research assistant. Minimally injured patients will be compared to those with a systolic blood pressure of 90 mmHg or less, the need for blood product transfusion within 1 hour of admission, and/or an ISS (injury severity score) of greater than or equal to 15. Demographic data including past medical/medication history as well as clinical data including continuous vital signs will be recorded. If eligibility criteria are met, the research blood samples will be drawn at the same time as routine clinical samples. Blood samples (approximately 15 ml) will be taken on admission, 3hr, 6hrs, 12hrs, 24 hrs, 48 hrs, and 5 days post admission. Vital signs, number of blood transfusions, volume of crystalloid, administration of medications, and the values of routine laboratories will be monitored continuously for 24 hours, and then cumulatively for up to 5 days. After the last blood draw, we will be following the patient's outcome for up to 30 days. If patients are discharged or die prior to completing the 5 days of blood samples, additional samples and/or clinic appointments for the purpose of research will not be obtained. A computational algorithm will be used to predict the development of trauma induced coagulopathy, inflammation and multi-organ failure.

Study Timeline

• Study Start: 2017-02-27
• Study First Submitted: 2017-03-15
• Study First Submitted QC: 2017-04-24
• Study First Posted: 2017-04-25
• Primary Completion: 2020-12-31
• Study Completion: 2020-12-31
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-08
• Last Update Posted: 2021-03-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

• Injured patients presenting to the trauma bay with a trauma alert activation (highest level of activation)
• Age 18 years old or more

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Exclusion Criteria

• Transfer duration to trauma service exceeding 6 hours.
• Known pregnancy

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Trauma patients	Computational model	Trauma patients with a systolic blood pressure of 90 mmHg or less, in need for blood product transfusion within 1 hour of admission, and/or an ISS (injury severity score) of greater than or equal to 15.
Trauma patients	Thromboelastography	Trauma patients with a systolic blood pressure of 90 mmHg or less, in need for blood product transfusion within 1 hour of admission, and/or an ISS (injury severity score) of greater than or equal to 15.

Primary Outcome Measures

Name	Time	Method
Change in Thromboelastography parameters T0 -T3	Between time of admission (T0) and 3 hours (T3)	Variables: Reaction time (R value), the K value, the angle and the maximum amplitude (MA)
Change in Thromboelastography parameters T24 - T48	Between 24 hours (T24) and 48 hours (T48)	Variables: Reaction time (R value), the K value, the angle and the maximum amplitude (MA)
Change in Thromboelastography parameters T6 -T12	Between 6 hours (T6) and 12 hours (T12)	Variables: Reaction time (R value), the K value, the angle and the maximum amplitude (MA)
Change in Thromboelastography parameters T3 -T6	Between 3 hours (T3) and 6 hours (T6)	Variables: Reaction time (R value), the K value, the angle and the maximum amplitude (MA)
Change in Thromboelastography parameters T12 - T24	Between 12 hours (T12) and 24 hours (T24)	Variables: Reaction time (R value), the K value, the angle and the maximum amplitude (MA)
Change in Thromboelastography parameters T48 - T120	Between 48 hours (T48) and 120 hours (T120)	Variables: Reaction time (R value), the K value, the angle and the maximum amplitude (MA)

Trial Locations

Locations (1)

Penn Presbyterian Medical Center; 🇺🇸 Philadelphia, Pennsylvania, United States