Trauma Induced Coagulopathy and Inflammation
| Status: | Recruiting |
|---|---|
| Conditions: | Hospital, Hematology |
| Therapuetic Areas: | Hematology, Other |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 8/11/2018 |
| Start Date: | February 27, 2017 |
| End Date: | February 2020 |
| Contact: | Steve Balian, MD |
| Email: | steve.balian@uphs.upenn.edu |
| Phone: | 215-662-8924 |
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.
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.
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.
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.
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
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