Clinical trial NCT03128658: Trauma Induced Coagulopathy and Inflammation
Official title: Trauma Induced Coagulopathy and Inflammation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Trauma Injury
Trauma
Coagulopathy
Keywords: Trauma induced coagulopathy
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: Princeton University
First posted: 2017-04-25
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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

Primary outcomes:
measure: Change in Thromboelastography parameters T0 -T3
timeFrame: Between time of admission (T0) and 3 hours (T3)
measure: Change in Thromboelastography parameters T3 -T6
timeFrame: Between 3 hours (T3) and 6 hours (T6)
measure: Change in Thromboelastography parameters T6 -T12
timeFrame: Between 6 hours (T6) and 12 hours (T12)
measure: Change in Thromboelastography parameters T12 - T24
timeFrame: Between 12 hours (T12) and 24 hours (T24)
measure: Change in Thromboelastography parameters T24 - T48
timeFrame: Between 24 hours (T24) and 48 hours (T48)
measure: Change in Thromboelastography parameters T48 - T120
timeFrame: Between 48 hours (T48) and 120 hours (T120)
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Penn Presbyterian Medical Center
state: Pennsylvania
Study officials:
References: