Trauma Induced Coagulopathy and Inflammation

NCT ID: NCT03128658

Last Updated: 2021-03-09

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 300 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-02-27
• Study Completion Date: 2020-12-31

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.

Conditions

Trauma Injury; Trauma; Coagulopathy

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Thromboelastography

Intervention Type: 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

Intervention Type: 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.

Interventions

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)

Intervention Type: 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.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Princeton University

OTHER

Sponsor Role: collaborator

University of Pennsylvania

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Penn Presbyterian Medical Center

Philadelphia, Pennsylvania, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

826515

Identifier Type: -

Identifier Source: org_study_id