Post-Injury Platelet Biology: Mechanisms and Outcomes

NCT03682757 | Completed

• 2 other identifiers: P05282965K23GM130892
• Study Type: observational
• Target: 367
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Wound and Injuries; Blood Platelets; Endothelium

Keywords

Trauma; Platelets; Coagulopathy

Outcome Measures

Primary Outcomes (10)

• In Vitro Measurement of Endothelial Biomarkers

  Plasma biomarkers of endothelial injury will be measured by enzyme-linked immunosorbent assays (von Willebrand factor, syndecan-1, and angiopoietin-2).

  0 hour (within 10 minutes of arrival to the Emergency Department)

• In Vitro Measurement Platelet Activation Biomarkers

  Cellular biomarkers of platelet activation will be measured by flow cytometry (platelet-monocyte aggregates, integrin αIIbβ3, P-selectin, and platelet microparticles).

  0 hour (within 10 minutes of arrival to the Emergency Department)

• In Vitro Measurement of Platelet Aggregation

  Platelet aggregation will be measured by whole blood multiple electrode impedance aggregometry.

  0 hour (within 10 minutes of arrival to the Emergency Department)

• In Vitro Assays of Platelet-Induced Endothelial Permeability

  The effect of post-injury platelets on endothelial integrity will be quantified by in vitro assays of platelet-induced endothelial permeability using transendothelial permeability electrical resistance (TEER) assays.

  0 hour (within 10 minutes of arrival to the Emergency Department)

• Transfusion products received (red cell, plasma, platelet)

  Continuous units of red cell, plasma, platelet; transfused in 24 hours (yes/no); massive transfusion (\>10units red cell/24 hour, yes/no)

  in first 24 hours after arrival to the emergency department

• Organ Failure

  Rates of organ failure (yes/no) (Denver Postinjury Multiple Organ Failure Score)

  Within 1 week of arrival to the emergency department

• 6-hour Mortality

  6 hours after arrival to the emergency department

• 24-hour Mortality

  24 hours after arrival to the emergency department

• 30-days Mortality

  30 days after arrival to the emergency department

• Hospital Discharge Mortality

  Through hospital discharge (an average of 13 days)

Study Arms (3)

Severe Injury/Shock

Severely injured trauma patients presenting with shock, as defined by an Injury Severity Score (ISS)\>=25, and base deficit (BD)\>=6.

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.

Healthy Controls

Uninjured healthy volunteers

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients meeting criteria for full trauma team activation and admitted to Zuckerberg San Francisco General Hospital

You may qualify if:

• Adult patients meeting criteria for full trauma team activation and admitted to Zuckerberg San Francisco General Hospital.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of California, San Francisco: lead
• University of Colorado, Denver: collaborator
• University of Utah: collaborator
• University of California, Berkeley: collaborator
• National Institute of General Medical Sciences (NIGMS): collaborator

Study Sites (1)

Zuckerberg San Francisco General Hospital

San Francisco, California, 94110, United States

Location

Related Publications (53)

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Biospecimen

Retention: SAMPLES WITHOUT DNA

Whole blood, plasma

MeSH Terms

Conditions

Wounds and Injuries; Hemostatic Disorders

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Hemorrhagic Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Lucy Kornblith, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 17, 2018
• First Posted: September 25, 2018
• Study Start: September 20, 2018
• Primary Completion: September 30, 2023
• Study Completion: September 30, 2023
• Last Updated: December 8, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)