Trauma Induced Coagulopathy and Inflammation

Trauma Clinical Trial

— TrICI  

Official title:

Trauma Induced Coagulopathy and Inflammation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03128658
• Other study ID #: 826515
• Status: Completed
• Start date: February 27, 2017
• Est. completion date: December 31, 2020

Study information

• Verified date: March 2021
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Blood Coagulation Disorders
• Coagulopathy
• Hemostatic Disorders
• Inflammation
• Trauma
• Trauma Injury
• Wounds and Injuries

Intervention

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)
• 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.

Locations

Country	Name	City	State
United States	Penn Presbyterian Medical Center	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pennsylvania	Princeton University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)