Wound and InjuriesNCT03682757
Post-Injury Platelet Biology: Mechanisms and Outcomes
An observational study of Wound and Injuries and Blood Platelets, run by University of California, San Francisco at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Wound and Injuries, Blood Platelets, Endothelium
- How many people
- 367 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Sep 2018to 30 Sep 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adult patients meeting criteria for full trauma team activation and admitted to Zuckerberg San Francisco General Hospital
Who may be able to join
- Adult patients meeting criteria for full trauma team activation and admitted to Zuckerberg San Francisco General Hospital.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Zuckerberg San Francisco General Hospital
San Francisco, California, 94110
About this study
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.
Read the detailed description
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
- Wound and Injuries, Blood Platelets, Endothelium
- Keywords
- Trauma, Platelets, Coagulopathy
- Medical subject headings
- Wounds and Injuries, Hemostatic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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)
Measured: in first 24 hours after arrival to the emergency department
Organ Failure
Rates of organ failure (yes/no) (Denver Postinjury Multiple Organ Failure Score)
Measured: Within 1 week of arrival to the emergency department
6-hour Mortality
Measured: 6 hours after arrival to the emergency department
24-hour Mortality
Measured: 24 hours after arrival to the emergency department
30-days Mortality
Measured: 30 days after arrival to the emergency department
Hospital Discharge Mortality
Measured: Through hospital discharge (an average of 13 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2018
- Study start20 Sep 2018
- Primary completion30 Sep 2023
- Study completion30 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (53)Papers the sponsor has linked to this study.
- Other trials for Wound and InjuriesStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 367 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- University of Colorado, Denver, University of Utah, University of California, Berkeley, National Institute of General Medical Sciences (NIGMS)
- Responsible party
- Sponsor
- Investigators
- Lucy Kornblith, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03682757
- Sponsor's protocol ID
- P0528296
- Other IDs
- 5K23GM130892
- Status last verified
- Dec 2023
- First submitted
- 17 Sep 2018
- Last updated
- 8 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Norton R, Kobusingye O. Injuries. N Engl J Med. 2013 May 2;368(18):1723-30. doi: 10.1056/NEJMra1109343. No abstract available.
PubMed 23635052Cannon JW. Hemorrhagic Shock. N Engl J Med. 2018 Jan 25;378(4):370-379. doi: 10.1056/NEJMra1705649. No abstract available.
PubMed 29365303Kauvar DS, Lefering R, Wade CE. Impact of hemorrhage on trauma outcome: an overview of epidemiology, clinical presentations, and therapeutic considerations. J Trauma. 2006 Jun;60(6 Suppl):S3-11. doi: 10.1097/01.ta.0000199961.02677.19.
PubMed 16763478Cohen MJ, Christie SA. New understandings of post injury coagulation and resuscitation. Int J Surg. 2016 Sep;33(Pt B):242-245. doi: 10.1016/j.ijsu.2016.05.037. Epub 2016 May 19.
PubMed 27212591Brohi K, Singh J, Heron M, Coats T. Acute traumatic coagulopathy. J Trauma. 2003 Jun;54(6):1127-30. doi: 10.1097/01.TA.0000069184.82147.06.
PubMed 12813333MacLeod JB, Lynn M, McKenney MG, Cohn SM, Murtha M. Early coagulopathy predicts mortality in trauma. J Trauma. 2003 Jul;55(1):39-44. doi: 10.1097/01.TA.0000075338.21177.EF.
PubMed 12855879Baimukanova G, Miyazawa B, Potter DR, Gibb SL, Keating S, Danesh A, Beyer A, Dayter Y, Bruhn R, Muench MO, Cap AP, Norris PJ, Spinella P, Cohen M, Pati S. The effects of 22 degrees C and 4 degrees C storage of platelets on vascular endothelial integrity and function. Transfusion. 2016 Mar;56 Suppl 1:S52-64. doi: 10.1111/trf.13455.
PubMed 27001362Baimukanova G, Miyazawa B, Potter DR, Muench MO, Bruhn R, Gibb SL, Spinella PC, Cap AP, Cohen MJ, Pati S. Platelets regulate vascular endothelial stability: assessing the storage lesion and donor variability of apheresis platelets. Transfusion. 2016 Mar;56 Suppl 1(Suppl 1):S65-75. doi: 10.1111/trf.13532.
PubMed 27001364Kutcher ME, Redick BJ, McCreery RC, Crane IM, Greenberg MD, Cachola LM, Nelson MF, Cohen MJ. Characterization of platelet dysfunction after trauma. J Trauma Acute Care Surg. 2012 Jul;73(1):13-9. doi: 10.1097/TA.0b013e318256deab.
PubMed 22743367Davenport RA, Brohi K. Coagulopathy in trauma patients: importance of thrombocyte function? Curr Opin Anaesthesiol. 2009 Apr;22(2):261-6. doi: 10.1097/ACO.0b013e328325a6d9.
PubMed 19390252Brown LM, Call MS, Margaret Knudson M, Cohen MJ; Trauma Outcomes Group; Holcomb JB, Wade CE, Brasel KJ, Vercruysse G, MacLeod J, Dutton RP, Hess JR, Duchesne JC, McSwain NE, Muskat P, Johannigamn J, Cryer HM, Tillou A, Pittet JF, De Moya MA, Schreiber MA, Tieu B, Brundage S, Napolitano LM, Brunsvold M, Brunsvold M, Beilman G, Peitzman AB, Zenait MS, Sperry J, Alarcon L, Croce MA, Minei JP, Kozar R, Gonzalez EA, Stewart RM, Cohn SM, Mickalek JE, Bulger EM, Cotton BA, Nunez TC, Ivatury R, Meredith JW, Miller P, Pomper GJ, Marin B. A normal platelet count may not be enough: the impact of admission platelet count on mortality and transfusion in severely injured trauma patients. J Trauma. 2011 Aug;71(2 Suppl 3):S337-42. doi: 10.1097/TA.0b013e318227f67c.
PubMed 21814101Kornblith LZ, Kutcher ME, Redick BJ, Calfee CS, Vilardi RF, Cohen MJ. Fibrinogen and platelet contributions to clot formation: implications for trauma resuscitation and thromboprophylaxis. J Trauma Acute Care Surg. 2014 Feb;76(2):255-6; discussion 262-3. doi: 10.1097/TA.0000000000000108.
PubMed 24458031Li R, Elmongy H, Sims C, Diamond SL. Ex vivo recapitulation of trauma-induced coagulopathy and preliminary assessment of trauma patient platelet function under flow using microfluidic technology. J Trauma Acute Care Surg. 2016 Mar;80(3):440-9. doi: 10.1097/TA.0000000000000915.
PubMed 27082706Wohlauer MV, Moore EE, Thomas S, Sauaia A, Evans E, Harr J, Silliman CC, Ploplis V, Castellino FJ, Walsh M. Early platelet dysfunction: an unrecognized role in the acute coagulopathy of trauma. J Am Coll Surg. 2012 May;214(5):739-46. doi: 10.1016/j.jamcollsurg.2012.01.050.
PubMed 22520693Jacoby RC, Owings JT, Holmes J, Battistella FD, Gosselin RC, Paglieroni TG. Platelet activation and function after trauma. J Trauma. 2001 Oct;51(4):639-47. doi: 10.1097/00005373-200110000-00003.
PubMed 11586152
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-Injury Platelet Biology: Mechanisms and Outcomes
- ClinicalTrials.gov ID
- NCT03682757
- Acronym / sponsor ID
- P0528296
- Conditions
- Wound and Injuries, Blood Platelets, Endothelium
- Keywords
- Trauma, Platelets, Coagulopathy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 367 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- University of Colorado, Denver, University of Utah, University of California, Berkeley, National Institute of General Medical Sciences (NIGMS)
- Study start
- 20 Sep 2018 (actual)
- Primary completion
- 30 Sep 2023 (actual)
- Study completion
- 30 Sep 2023 (actual)
- First posted
- 25 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients meeting criteria for full trauma team activation and admitted to Zuckerberg San Francisco General Hospital
Key inclusion criteria (1 listed)
- Adult patients meeting criteria for full trauma team activation and admitted to Zuckerberg San Francisco General Hospital.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2023.
- Background: PubMed 23635052Norton R, Kobusingye O. Injuries. N Engl J Med. 2013 May 2;368(18):1723-30. doi: 10.1056/NEJMra1109343. No abstract available.
- Background: PubMed 29365303Cannon JW. Hemorrhagic Shock. N Engl J Med. 2018 Jan 25;378(4):370-379. doi: 10.1056/NEJMra1705649. No abstract available.
- Background: PubMed 16763478Kauvar DS, Lefering R, Wade CE. Impact of hemorrhage on trauma outcome: an overview of epidemiology, clinical presentations, and therapeutic considerations. J Trauma. 2006 Jun;60(6 Suppl):S3-11. doi: 10.1097/01.ta.0000199961.02677.19.
- Background: PubMed 27212591Cohen MJ, Christie SA. New understandings of post injury coagulation and resuscitation. Int J Surg. 2016 Sep;33(Pt B):242-245. doi: 10.1016/j.ijsu.2016.05.037. Epub 2016 May 19.
- Background: PubMed 12813333Brohi K, Singh J, Heron M, Coats T. Acute traumatic coagulopathy. J Trauma. 2003 Jun;54(6):1127-30. doi: 10.1097/01.TA.0000069184.82147.06.
- Background: PubMed 12855879MacLeod JB, Lynn M, McKenney MG, Cohn SM, Murtha M. Early coagulopathy predicts mortality in trauma. J Trauma. 2003 Jul;55(1):39-44. doi: 10.1097/01.TA.0000075338.21177.EF.
- Background: PubMed 27001362Baimukanova G, Miyazawa B, Potter DR, Gibb SL, Keating S, Danesh A, Beyer A, Dayter Y, Bruhn R, Muench MO, Cap AP, Norris PJ, Spinella P, Cohen M, Pati S. The effects of 22 degrees C and 4 degrees C storage of platelets on vascular endothelial integrity and function. Transfusion. 2016 Mar;56 Suppl 1:S52-64. doi: 10.1111/trf.13455.
- Background: PubMed 27001364Baimukanova G, Miyazawa B, Potter DR, Muench MO, Bruhn R, Gibb SL, Spinella PC, Cap AP, Cohen MJ, Pati S. Platelets regulate vascular endothelial stability: assessing the storage lesion and donor variability of apheresis platelets. Transfusion. 2016 Mar;56 Suppl 1(Suppl 1):S65-75. doi: 10.1111/trf.13532.
- Background: PubMed 22743367Kutcher ME, Redick BJ, McCreery RC, Crane IM, Greenberg MD, Cachola LM, Nelson MF, Cohen MJ. Characterization of platelet dysfunction after trauma. J Trauma Acute Care Surg. 2012 Jul;73(1):13-9. doi: 10.1097/TA.0b013e318256deab.
- Background: PubMed 19390252Davenport RA, Brohi K. Coagulopathy in trauma patients: importance of thrombocyte function? Curr Opin Anaesthesiol. 2009 Apr;22(2):261-6. doi: 10.1097/ACO.0b013e328325a6d9.
- Background: PubMed 21814101Brown LM, Call MS, Margaret Knudson M, Cohen MJ; Trauma Outcomes Group; Holcomb JB, Wade CE, Brasel KJ, Vercruysse G, MacLeod J, Dutton RP, Hess JR, Duchesne JC, McSwain NE, Muskat P, Johannigamn J, Cryer HM, Tillou A, Pittet JF, De Moya MA, Schreiber MA, Tieu B, Brundage S, Napolitano LM, Brunsvold M, Brunsvold M, Beilman G, Peitzman AB, Zenait MS, Sperry J, Alarcon L, Croce MA, Minei JP, Kozar R, Gonzalez EA, Stewart RM, Cohn SM, Mickalek JE, Bulger EM, Cotton BA, Nunez TC, Ivatury R, Meredith JW, Miller P, Pomper GJ, Marin B. A normal platelet count may not be enough: the impact of admission platelet count on mortality and transfusion in severely injured trauma patients. J Trauma. 2011 Aug;71(2 Suppl 3):S337-42. doi: 10.1097/TA.0b013e318227f67c.
- Background: PubMed 24458031Kornblith LZ, Kutcher ME, Redick BJ, Calfee CS, Vilardi RF, Cohen MJ. Fibrinogen and platelet contributions to clot formation: implications for trauma resuscitation and thromboprophylaxis. J Trauma Acute Care Surg. 2014 Feb;76(2):255-6; discussion 262-3. doi: 10.1097/TA.0000000000000108.
- Individual participant dataSharing planned: No
Related trials for Wound and Injuries
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Recruiting
NightWare and Cardiovascular Health in Women With PTSD
Post Traumatic Stress Disorder, Cardiovascular Diseases
Not yet recruiting
Safety Study of Microlyte DualGuard
Wound Closure, Wound Care
Enrolling by invitation
Personalized Ventilator Settings for Patients on ECMO
Acute Respiratory Distress Syndrome (ARDS), Extracorporeal Membrane Oxygenation
Recruiting
Effects of Cervicothoracic Mobilization in Patients With Supraspinatus Tendinitis
Rotator Cuff Tendonitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lucy Kornblith, MD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Wound and Injuries and Blood Platelets, run by University of California, San Francisco at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
In Vitro Measurement of Endothelial Biomarkers (time frame: 0 hour (within 10 minutes of arrival to the Emergency Department)). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03682757, which also lists 53 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2023.