Trauma Clinical Trial - Trauma Induced Coagulopathy & Inflammation

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03128658
Study type	Observational
Source	University of Pennsylvania
Contact
Status	Completed
Phase
Start date	February 27, 2017
Completion date	December 31, 2020

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT04848376` - Post-Market Clinical Follow-up Study of A-SPINE's Products
Terminated	`NCT03781817` - Intranasal Versus Intravenous Ketamine for Procedural Sedation in Children With Non-operative Fractures	Phase 4
Completed	`NCT04342416` - Using a Brief Visuospatial Interference Intervention to Reduce Intrusive Memories Among Trauma Exposed Women	N/A
Recruiting	`NCT04856449` - DBT Skills Plus EMDR for BPD and Trauma	N/A
Completed	`NCT04356963` - Adjunct VR Pain Management in Acute Brain Injury	N/A
Completed	`NCT05669313` - The Effects of Hypothermia and Acidosis on Coagulation During Treatment With Rivaroxaban Measured With ROTEM
Active, not recruiting	`NCT03622632` - Pilot Study to Measure Uric Acid in Traumatized Patients: Determinants and Prognostic Association
Recruiting	`NCT04725721` - Testing FIRST in Youth Outpatient Psychotherapy	N/A
Active, not recruiting	`NCT05530642` - An Augmented Training Program for Preventing Post-Traumatic Stress Injuries Among Diverse Public Safety Personnel	N/A
Not yet recruiting	`NCT05649891` - Checklists Resuscitation Emergency Department	N/A
Not yet recruiting	`NCT03696563` - FreeO2 PreHospital - Automated Oxygen Titration vs Manual Titration According to the BLS-PCS	N/A
Withdrawn	`NCT03249129` - Identification of Autoantibodies and Autoantigens in the Cerebrospinal Fluid of Patients With Spinal Cord Trauma
Completed	`NCT02240732` - Surgical Tourniquets and Cerebral Emboli	N/A
Completed	`NCT02227979` - Effects of PURPLE Cry Intervention	N/A
Withdrawn	`NCT01169025` - Fentanyl vs. Low-Dose Ketamine for the Relief of Moderate to Severe Pain in Aeromedical Patients	N/A
Recruiting	`NCT01812941` - Evaluation of Mitochondrial Dysfunction in Severe Burn and Trauma Patients	N/A
Completed	`NCT01475344` - Fibrinogen Concentrate (FGTW) in Trauma Patients, Presumed to Bleed (FI in TIC)	Phase 1/Phase 2
Completed	`NCT03112304` - Child STEPS for Youth Mental Health in Maine Sustainability	N/A
Completed	`NCT01201863` - Neuroendocrine Dysfunction in Traumatic Brain Injury: Effects of Testosterone Therapy	Phase 4
Completed	`NCT01210417` - Trauma Heart to Arm Time	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Trauma Induced Coagulopathy and Inflammation — TrICI

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms