Trauma Induced Coagulopathy and Inflammation

NCT03128658 | Completed

• 1 other identifier: 826515
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Trauma Injury; Trauma; Coagulopathy

Keywords

Trauma induced coagulopathy

Outcome Measures

Primary Outcomes (6)

• 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)

Study Arms (1)

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; Diagnostic Test: Computational model

Interventions

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)

Trauma patients

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.

Trauma patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Pennsylvania: lead
• Princeton University: collaborator

Study Sites (1)

Penn Presbyterian Medical Center

Philadelphia, Pennsylvania, 19104, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

During the initial trauma evaluation, 15 ml of blood will be collected for research purposes during the routine blood trauma blood draw. Additional 15 ml samples will be collected at 3 hours, 6 hours, 12 hours, 24 hours, 48 hours and 5 days post admission. Blood samples will be analyzed for coagulation parameters using thromboelastography.

MeSH Terms

Conditions

Accidental Injuries; Wounds and Injuries; Hemostatic Disorders

Interventions

Thrombelastography

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Hemorrhagic Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Blood Coagulation Tests; Hematologic Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 15, 2017
• First Posted: April 25, 2017
• Study Start: February 27, 2017
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2020
• Last Updated: March 9, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)