CompletedNot Applicable

Trauma Induced Coagulopathy and Inflammation

United States300 participantsStarted 2017-02-27

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in Thromboelastography parameters T0 -T3

Timeframe: Between time of admission (T0) and 3 hours (T3)

Change in Thromboelastography parameters T3 -T6

Timeframe: Between 3 hours (T3) and 6 hours (T6)

Change in Thromboelastography parameters T6 -T12

Timeframe: Between 6 hours (T6) and 12 hours (T12)

Change in Thromboelastography parameters T12 - T24

Timeframe: Between 12 hours (T12) and 24 hours (T24)

Change in Thromboelastography parameters T24 - T48

Timeframe: Between 24 hours (T24) and 48 hours (T48)

Change in Thromboelastography parameters T48 - T120

Timeframe: Between 48 hours (T48) and 120 hours (T120)

Trial details

NCT IDNCT03128658

SponsorUniversity of Pennsylvania

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2020-12-31

View on ClinicalTrials.gov More Trauma Injury trials