Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
COMPLETED
Total Enrollment
367 participants
Study Classification
OBSERVATIONAL
Study Start Date
2018-09-20
Study Completion Date
2023-09-30
Brief Summary
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Trauma-induced coagulopathy is a central cause of preventable deaths from hemorrhage after injury. The contribution and impact of altered post injury platelet biology on trauma-induced coagulopathy is not well understood despite the pivotal contribution of platelets to normal coagulation and endothelial integrity. The central hypothesis for this study is that severe injury and shock drive altered platelet activation, platelet aggregation, and platelet-endothelial interactions that are associated with increased rates of transfusion, organ failure, and mortality. This study will investigate these causal pathways, mechanisms, and associated outcomes in a prospective observational trauma cohort through collection of biospecimens and detailed clinical data.
Detailed Description
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This is a prospective cohort study of trauma patients on admission to the emergency department and for the subsequent 28 days. All adult patients meeting criteria for full trauma team activation and admitted to Zuckerberg San Francisco General Hospital and Trauma center, a level-1 trauma center, are eligible for enrollment. A 20-ml sample of blood will be drawn within 10 minutes of arrival in the emergency department (ED), processed in the central laboratory, and plasma stored at -80°C. Blood samples will be collected immediately on presentation via initial placement of a 16-gauge or larger peripheral intravenous line. Plasma biomarkers of endothelial injury will be measured by enzyme-linked immunosorbent assays (von Willebrand factor, syndecan-1, and angiopoietin-2). Cellular biomarkers of platelet activation will be measured by flow cytometry (platelet-monocyte aggregates, integrin αIIbβ3, P-selectin, and platelet microparticles). Platelet aggregation will be measured by whole blood multiple electrode impedance aggregometry. The effect of post-injury platelets on endothelial integrity will be quantified by in vitro assays of platelet-induced endothelial permeability. Comprehensive demographic data and medical history will be collected from chart review, interviews of patients and family members. Detailed clinical and outcome data is collected including transfusion timing and doses, the incidence of organ failure (Denver Postinjury Multiple Organ Failure Score), acute respiratory distress syndrome (Berlin Definition), infection, symptomatic thromboembolic complications, ventilator-free days, length of intensive care unit (ICU) and hospital stay, and mortality (6 hours, 24 hours, 30 days). In hospital mortality after 30 days will be assessed for all patients. Standard coagulation measures (international normalized ratio, prothrombin time, platelet count) and other laboratory measures will be collected to account and control for other distinct but highly integrated pathways implicated in trauma-induced coagulopathy. The Trauma Registry, a large database managed under guidelines from the American Trauma society, uses chart review to retrospectively assign Injury Severity Scores (ISS) and Abbreviated Injury Scores (AIS).
Conditions
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Wound and Injuries
Blood Platelets
Endothelium
Keywords
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Trauma
Platelets
Coagulopathy
Study Design
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Observational Model Type
COHORT
Study Time Perspective
PROSPECTIVE
Study Groups
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Severe Injury/Shock
Severely injured trauma patients presenting with shock, as defined by an Injury Severity Score (ISS)\>=25, and base deficit (BD)\>=6.
No interventions assigned to this group
Without Severe Injury/Shock
Not severely injured trauma patients presenting without shock, as defined by an Injury Severity Score (ISS)\<25, and base deficit (BD) \<6.
No interventions assigned to this group
Healthy Controls
Uninjured healthy volunteers
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Adult patients meeting criteria for full trauma team activation and admitted to Zuckerberg San Francisco General Hospital.
Exclusion Criteria
* Patients \<18 years old
* Patients transferred from other hospitals
* Patients who are pregnant
* Patients who are incarcerated
* Patients will be retrospectively excluded if they were taking anticoagulant or anti-platelet medications, have moderate or severe liver disease, or a known bleeding diathesis.
* Patients transferred from other hospitals
* Patients who are pregnant
* Patients who are incarcerated
* Patients will be retrospectively excluded if they were taking anticoagulant or anti-platelet medications, have moderate or severe liver disease, or a known bleeding diathesis.
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
Yes
Sponsors
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University of Colorado, Denver
OTHER
Sponsor Role
collaborator
University of Utah
OTHER
Sponsor Role
collaborator
University of California, Berkeley
OTHER
Sponsor Role
collaborator
National Institute of General Medical Sciences (NIGMS)
NIH
Sponsor Role
collaborator
University of California, San Francisco
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Lucy Kornblith, MD
Role: PRINCIPAL_INVESTIGATOR
University of California, San Francisco
Locations
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Zuckerberg San Francisco General Hospital
San Francisco, California, United States
Site Status
Countries
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United States
References
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Other Identifiers
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P0528296
Identifier Type: -
Identifier Source: org_study_id