Microvesicle Production After Acute Trauma and Its Clinical Impact on Venothromboembolism
1 other identifier
observational
1,234
1 country
1
Brief Summary
The purpose of this research study is to look at how trauma affects the ability of blood to clot. The blood of people who suffer a traumatic injury can under-clot or over-clot, and this research study will look at blood drawn from people after they suffer a traumatic injury to see how well their blood clots.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2011
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 20, 2010
CompletedFirst Posted
Study publicly available on registry
December 21, 2010
CompletedStudy Start
First participant enrolled
January 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 14, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
December 14, 2014
CompletedApril 8, 2021
April 1, 2021
4 years
December 20, 2010
April 6, 2021
Conditions
Outcome Measures
Primary Outcomes (2)
Estimate the distribution over time of procoagulant Microvesicles (MVs) concentration by cell of origin and endogenous thrombin potential (ETP).
6 months
Determine the cumulative incidence of Venothromboembolism (VTE) within three months after major trauma and test the distribution of procoagulant MV concentration and endogenous thrombin generation potential over time as potential predictors of VTE.
4 years
Study Arms (2)
Traumatic Injury
Trauma patients arriving at Saint Mary's Emergency Department
Control group
Eligibility Criteria
Trauma patients arriving to Saint Mary's Emergency Department and control patients.
You may qualify if:
- Male and female patients 18 years of age or older
- Blunt trauma patients including those with closed head injury
- Penetrating trauma patients
You may not qualify if:
- Are on therapeutic anticoagulation
- Have preexisting coagulopathy
- Patients greater than 12 hours from time of injury
- Have history of malignancy or preexisting diagnosis of sepsis or renal failure
- Patients with burn injuries
- Male and female patients younger than 18 years of age
- Pregnant patients
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mayo Cliniclead
Study Sites (1)
Mayo Clinic in Rochester
Rochester, Minnesota, 55905, United States
Related Links
Study Officials
- PRINCIPAL INVESTIGATOR
Myung Park, M.D.
Mayo Clinic
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor of Surgery
Study Record Dates
First Submitted
December 20, 2010
First Posted
December 21, 2010
Study Start
January 1, 2011
Primary Completion
December 14, 2014
Study Completion
December 14, 2014
Last Updated
April 8, 2021
Record last verified: 2021-04
Data Sharing
- IPD Sharing
- Will not share