Trauma Induced Coagulopathy and Inflammation (TrICI)

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.

Study Overview

• Status: Completed
• Conditions: Trauma; Trauma Injury; Coagulopathy
• Intervention / Treatment: Diagnostic test: Thromboelastography; Diagnostic test: Computational model

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 Type: Observational
• Enrollment (Actual): 300

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Penn Presbyterian Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Trauma patients 18 years or older who present to the trauma bay as a trauma alert (highest level of activation), requiring blood product transfusion within 1 hour of admission, and/or having an injury severity score (ISS) greater than or equal to 15.

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Trauma patients; 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.

Diagnostic test: Thromboelastography; Thromboelastography (TEG) tests for parameters related to efficiency of blood coagulation. The parameters are: reaction time (R value), the K value, the angle and the maximum amplitude (MA); Diagnostic test: Computational model; The computational whole-patient systems model is a multiscale, multi-compartment model whose state-space is defined by a very large and heterogeneous set of variables as well as a large number of input parameters. The model will be integrated in time for various initial trauma conditions in an attempt to determine whether the model can be predictive, and help us discover new variables that are more predictive of clinical outcomes than those employed in current clinical protocols.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Pennsylvania
• Collaborators: Princeton University

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 27, 2017
• Primary Completion (ACTUAL): December 31, 2020
• Study Completion (ACTUAL): December 31, 2020

Study Registration Dates

• First Submitted: March 15, 2017
• First Submitted That Met QC Criteria: April 24, 2017
• First Posted (ACTUAL): April 25, 2017

Study Record Updates

• Last Update Posted (ACTUAL): March 9, 2021
• Last Update Submitted That Met QC Criteria: March 8, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: Trauma induced coagulopathy
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Hematologic Diseases; Hemorrhagic Disorders; Hemostatic Disorders; Blood Coagulation Disorders; Inflammation; Wounds and Injuries
• Other Study ID Numbers: 826515

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No