Post-Injury Platelet Biology: Mechanisms and Outcomes
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|ClinicalTrials.gov Identifier: NCT03682757|
Recruitment Status : Recruiting
First Posted : September 25, 2018
Last Update Posted : August 20, 2020
|Condition or disease|
|Wound and Injuries Blood Platelets Endothelium|
|Study Type :||Observational|
|Estimated Enrollment :||300 participants|
|Official Title:||Post-Injury Platelet Biology: Mechanisms and Outcomes|
|Actual Study Start Date :||September 20, 2018|
|Estimated Primary Completion Date :||September 2023|
|Estimated Study Completion Date :||September 2023|
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.
Uninjured healthy volunteers
- In Vitro Measurement of Endothelial Biomarkers [ Time Frame: 0 hour (within 10 minutes of arrival to the Emergency Department) ]Plasma biomarkers of endothelial injury will be measured by enzyme-linked immunosorbent assays (von Willebrand factor, syndecan-1, and angiopoietin-2).
- In Vitro Measurement Platelet Activation Biomarkers [ Time Frame: 0 hour (within 10 minutes of arrival to the Emergency Department) ]Cellular biomarkers of platelet activation will be measured by flow cytometry (platelet-monocyte aggregates, integrin αIIbβ3, P-selectin, and platelet microparticles).
- In Vitro Measurement of Platelet Aggregation [ Time Frame: 0 hour (within 10 minutes of arrival to the Emergency Department) ]Platelet aggregation will be measured by whole blood multiple electrode impedance aggregometry.
- In Vitro Assays of Platelet-Induced Endothelial Permeability [ Time Frame: 0 hour (within 10 minutes of arrival to the Emergency Department) ]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.
- Transfusion products received (red cell, plasma, platelet) [ Time Frame: in first 24 hours after arrival to the emergency department ]Continuous units of red cell, plasma, platelet; transfused in 24 hours (yes/no); massive transfusion (>10units red cell/24 hour, yes/no)
- Organ Failure [ Time Frame: Within 1 week of arrival to the emergency department ]Rates of organ failure (yes/no) (Denver Postinjury Multiple Organ Failure Score)
- 6-hour Mortality [ Time Frame: 6 hours after arrival to the emergency department ]
- 24-hour Mortality [ Time Frame: 24 hours after arrival to the emergency department ]
- 30-days Mortality [ Time Frame: 30 days after arrival to the emergency department ]
- Hospital Discharge Mortality [ Time Frame: Through hospital discharge (an average of 13 days) ]
Biospecimen Retention: Samples Without DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03682757
|Contact: Lucy Kornblith, MD||415-206-6946||Lucy.Kornblith@ucsf.edu|
|United States, California|
|Zuckerberg San Francisco General Hospital||Recruiting|
|San Francisco, California, United States, 94110|
|Contact: Lucy Kornblith, MD 415-206-6946 Lucy.Kornblith@ucsf.edu|
|Principal Investigator:||Lucy Kornblith, MD||University of California, San Francisco|