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Completed

NCT Number: NCT03128658

Trauma Induced Coagulopathy and Inflammation

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.

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Key information

Conditions

Trauma Injury Accidental Injuries Cardiovascular Diseases Coagulopathy Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Trauma Vascular Diseases Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Penn Presbyterian Medical Center

Philadelphia, Pennsylvania, 19104, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

thromboelastography

Diagnostic Test

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)

Computational model

Diagnostic Test

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.

Primary outcomes

  1. Change in Thromboelastography parameters T0 -T3

    Time frame: Between time of admission (T0) and 3 hours (T3)

    Variables: Reaction time (R value), the K value, the angle and the maximum amplitude (MA)

  2. Change in Thromboelastography parameters T3 -T6

    Time frame: Between 3 hours (T3) and 6 hours (T6)

    Variables: Reaction time (R value), the K value, the angle and the maximum amplitude (MA)

  3. Change in Thromboelastography parameters T6 -T12

    Time frame: Between 6 hours (T6) and 12 hours (T12)

    Variables: Reaction time (R value), the K value, the angle and the maximum amplitude (MA)

  4. Change in Thromboelastography parameters T12 - T24

    Time frame: Between 12 hours (T12) and 24 hours (T24)

    Variables: Reaction time (R value), the K value, the angle and the maximum amplitude (MA)

  5. Change in Thromboelastography parameters T24 - T48

    Time frame: Between 24 hours (T24) and 48 hours (T48)

    Variables: Reaction time (R value), the K value, the angle and the maximum amplitude (MA)

  6. Change in Thromboelastography parameters T48 - T120

    Time frame: Between 48 hours (T48) and 120 hours (T120)

    Variables: Reaction time (R value), the K value, the angle and the maximum amplitude (MA)

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Collaborators

  • Princeton University

Registry information

Acronym: TrICI

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Apr 25, 2017
Registry last updated
Mar 9, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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